Pilot Study of Infusion of Fucosylated Regulatory T Cells to Prevent Graft Versus Host Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Severe Infusional Toxicity
研究概览
简要总结
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.
T-cells are white blood cells that are important to the immune system. The T cells for this study (called regulatory T-cells, or Tregs) will be from a donor who is not related to you. Before the Tregs are given to you, they may be changed in the laboratory to make use of sugar that is found in small amounts in blood cells through a process called fucosylation. They are then called fucosylated Tregs. Adding more sugars to the Tregs in the laboratory is designed to help the Tregs find their way faster to the bone marrow, which may help low blood counts to recover faster.
The goal of this clinical research study is to learn if it is safe and practical to give fucosylated Tregs to patients who will receive a matched related donor (MRD), a matched unrelated donor (MUD), or cord blood transplant. Researchers also want to learn if these Tregs may prevent or reduce the effects of graft-versus host disease (GVHD). GVHD can result from a reaction of the transplanted cord blood cells against certain tissues in the body.
This is an investigational study. Fucosylation of Tregs is not an FDA-approved process. It is currently being used for research purposes only. Fludarabine, melphalan, cyclophosphamide and rituximab are FDA approved and commercially available to be given to patients with leukemia or lymphoma having a cord blood transplant. Total body irradiation is delivered using FDA-approved and commercially available methods.
Up to 47 patients will take part in this study. All will be enrolled at MD Anderson.
详细描述
Central Venous Catheter Placement:
You will first have a central venous catheter (CVC) placed. A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for it.
The chemotherapy, some of the other drugs in this study, the Tregs, and the MRD, MUD or cord blood transplant will be given by vein through your CVC. Some blood samples will also be drawn through your CVC. The CVC will remain in your body for about 2-5 months.
Study Treatments:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of Tregs based on when you joined this study. You may receive fucosylated or non-fucosylated Treg cells. Two dose levels of fucosylated Tregs will be tested. Up to 3 participants will be enrolled in Dose Level 1, and up to 17 will be in Dose Level 2. The first group of participants will receive the lower dose level. The next group will receive a higher dose than the first group, if no intolerable side effects were seen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with high risk hematologic malignancies, including those with induction failure and in relapse.
- •Patients must have matched related or matched unrelated donor source OR CB unit(s) available for the primary transplant which is/are matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens. The cord(s) must contain at least 3 x 107 total nucleated cells/Kg recipient body weight (pre-thaw).
- •Age Criteria: Age >/= 18 and </= 80 years old. Eligibility for pediatric patients will be determined in conjunction with an MDACC pediatrician.
- •Bilirubin </= 1.5 mg/dl, SGPT </= 200 IU/ml (unless Gilbert's syndrome).
- •Calculated creatinine clearance of >50 mL/min using the Cockcroft-Gault equation for adult patients 18 to 70 years old based on ideal body weight.
- •Diffusing capacity for carbon monoxide (DLCO) >/= 45% predicted corrected for hemoglobin. For children </= 7 years of age who unable to perform the pulmonary function test, an O2 saturation of >/= 92% on room air.
- •Left ventricular ejection fraction (LEF) >/= 40%.
- •Zubrod performance status </= 2 or Lansky of >/= 60%.
- •Twenty-one or more days must have elapsed since the patient's last radiation or chemotherapy administration before beginning treatment for stem cell transplant. Hydrea, Gleevec and other TKI inhibitors as well as intrathecal therapy are accepted exceptions.
- •A back-up graft identified, in case of graft failure, from any of the following sources: an available fraction of autologous marrow; or PBPCs harvested and cryopreserved; or family member donor; or a third cord blood unit.
- •Able to stop all CYP3A4 inhibitors (voriconazole or posaconazole) at least 7 days before admission.
排除标准
- •HIV seropositivity.
- •Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The PI is the final arbiter of eligibility.
- •Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or lactating females.
- •Unable to sign informed consent.
研究组 & 干预措施
Phase I: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Mesna administered on Day -8 immediately following completion of the Fludarabine.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Three (3) participants treated at cell dose level 1: 1 x 10^6/kg fucosylated T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD transplant on Day 0.
Mycophenolate 15 mg/kg by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Rituximab (Drug)
Phase I: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Mesna administered on Day -8 immediately following completion of the Fludarabine.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Three (3) participants treated at cell dose level 1: 1 x 10^6/kg fucosylated T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD transplant on Day 0.
Mycophenolate 15 mg/kg by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Fludarabine (Drug)
Phase I: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Mesna administered on Day -8 immediately following completion of the Fludarabine.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Three (3) participants treated at cell dose level 1: 1 x 10^6/kg fucosylated T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD transplant on Day 0.
Mycophenolate 15 mg/kg by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Cyclophosphamide (Drug)
Phase I: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Mesna administered on Day -8 immediately following completion of the Fludarabine.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Three (3) participants treated at cell dose level 1: 1 x 10^6/kg fucosylated T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD transplant on Day 0.
Mycophenolate 15 mg/kg by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Total Body Radiation (Radiation)
Phase I: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Mesna administered on Day -8 immediately following completion of the Fludarabine.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Three (3) participants treated at cell dose level 1: 1 x 10^6/kg fucosylated T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD transplant on Day 0.
Mycophenolate 15 mg/kg by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Fucosylated Regulatory T Cells (Procedure)
Phase I: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Mesna administered on Day -8 immediately following completion of the Fludarabine.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Three (3) participants treated at cell dose level 1: 1 x 10^6/kg fucosylated T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD transplant on Day 0.
Mycophenolate 15 mg/kg by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Cord Blood Infusions (Procedure)
Phase I: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Mesna administered on Day -8 immediately following completion of the Fludarabine.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Three (3) participants treated at cell dose level 1: 1 x 10^6/kg fucosylated T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD transplant on Day 0.
Mycophenolate 15 mg/kg by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Mycophenolate mofetil (Drug)
Phase I: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Mesna administered on Day -8 immediately following completion of the Fludarabine.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Three (3) participants treated at cell dose level 1: 1 x 10^6/kg fucosylated T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD transplant on Day 0.
Mycophenolate 15 mg/kg by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Sirolimus (Drug)
Phase I: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Mesna administered on Day -8 immediately following completion of the Fludarabine.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Three (3) participants treated at cell dose level 1: 1 x 10^6/kg fucosylated T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD transplant on Day 0.
Mycophenolate 15 mg/kg by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Bone Marrow Aspiration (Procedure)
Phase I: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Mesna administered on Day -8 immediately following completion of the Fludarabine.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Three (3) participants treated at cell dose level 1: 1 x 10^6/kg fucosylated T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD transplant on Day 0.
Mycophenolate 15 mg/kg by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: G-CSF (Drug)
Phase I: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Ten (10) participants treated with non-fucosylated T-reg cells at dose level 2: 1 x 10^7/kg T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Rituximab (Drug)
Phase I: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Ten (10) participants treated with non-fucosylated T-reg cells at dose level 2: 1 x 10^7/kg T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Fludarabine (Drug)
Phase I: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Ten (10) participants treated with non-fucosylated T-reg cells at dose level 2: 1 x 10^7/kg T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Cyclophosphamide (Drug)
Phase I: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Ten (10) participants treated with non-fucosylated T-reg cells at dose level 2: 1 x 10^7/kg T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Total Body Radiation (Radiation)
Phase I: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Ten (10) participants treated with non-fucosylated T-reg cells at dose level 2: 1 x 10^7/kg T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Cord Blood Infusions (Procedure)
Phase I: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Ten (10) participants treated with non-fucosylated T-reg cells at dose level 2: 1 x 10^7/kg T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Mycophenolate mofetil (Drug)
Phase I: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Ten (10) participants treated with non-fucosylated T-reg cells at dose level 2: 1 x 10^7/kg T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Sirolimus (Drug)
Phase I: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Ten (10) participants treated with non-fucosylated T-reg cells at dose level 2: 1 x 10^7/kg T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Bone Marrow Aspiration (Procedure)
Phase I: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Ten (10) participants treated with non-fucosylated T-reg cells at dose level 2: 1 x 10^7/kg T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: G-CSF (Drug)
Phase I: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
3rd party CB Treg infusion on Day -1.
Ten (10) participants treated with non-fucosylated T-reg cells at dose level 2: 1 x 10^7/kg T-reg cells. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Non-Fucosylated Regulatory T Cells (Procedure)
Phase II: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Rituximab (Drug)
Phase II: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Fludarabine (Drug)
Phase II: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Cyclophosphamide (Drug)
Phase II: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Total Body Radiation (Radiation)
Phase II: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Fucosylated Regulatory T Cells (Procedure)
Phase II: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Cord Blood Infusions (Procedure)
Phase II: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Mycophenolate mofetil (Drug)
Phase II: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Sirolimus (Drug)
Phase II: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Bone Marrow Aspiration (Procedure)
Phase II: Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: G-CSF (Drug)
Phase II: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Non-Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Rituximab (Drug)
Phase II: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Non-Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Fludarabine (Drug)
Phase II: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Non-Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Cyclophosphamide (Drug)
Phase II: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Non-Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Total Body Radiation (Radiation)
Phase II: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Non-Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Cord Blood Infusions (Procedure)
Phase II: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Non-Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Mycophenolate mofetil (Drug)
Phase II: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Non-Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Sirolimus (Drug)
Phase II: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Non-Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Bone Marrow Aspiration (Procedure)
Phase II: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Non-Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: G-CSF (Drug)
Phase II: Non-Fucosylated T-reg Cells + Chemotherapy
Rituximab 375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
Fludarabine 40 mg/m2 by vein on Days -8 to -5.
Cyclophosphamide 50 mg/kg by vein on Day -8.
Total body radiation 2 Gy delivered on Day -4.
Seventeen (17) participants treated with Non-Fucosylated T-reg cells at dose level 2: 1 x 10^7/kg. The cells are infused on Day -1.
Cord blood transplant, MRD, or MUD infused on Day 0.
Mycophenolate 15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
Sirolimus 12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
G-CSF 5 mcg/kg/day subcutaneously beginning on D+0 for CORD blood stem cell transplant and D+7 for allogeneic stem cell transplant, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
干预措施: Non-Fucosylated Regulatory T Cells (Procedure)
结局指标
主要结局
Severe Infusional Toxicity
时间窗: 100 days after the transplant
Severe infusional toxicity defined according to NCI CTCAE v4.0 (Prolonged (ie, not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae. Life-threatening consequences; urgent intervention indicated.)
Safety of Administering Fucosylated Umbilical Cord Blood (CB) Regulatory T cells (Tregs) in a CBT, MRD, or MUD Transplant
时间窗: 100 days after the transplant
For the purpose of safety monitoring, "failure" defined as F100 = \[T \< 100 days\]. The Bayesian method of Thall, et al.42 used for safety monitoring.
次要结局
- Time to Severe Graft Versus Host Disease (GVHD) or Death(100 days after the transplant)