NCT03483324已完成1 期
A Phase 1 Open-Label, Multi-Center Trial of AB-110 in Adults With Hematologic Malignancies Undergoing Cord
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Occurrence of adverse events grade 4 or grade 5 as assessed by CTCAEv4
研究概览
简要总结
A phase 1b, open label, multi-center trial of AB-110 in adults with hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplasia (MDS) undergoing cord blood transplantation. Subjects will receive unmanipulated cord blood (UCB) and AB-110 expanded CD34 enriched hematopoietic progenitor cells (HSPC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have received some immunosuppressive chemotherapy in the preceding 3 months.
- •Acute myelogenous leukemia (AML):
- •Complete first remission (CR1) at high risk for relapse
- •Complete second remission (CR2).
- •No documented myelofibrosis at screening marrow biopsy
- •Acute lymphoblastic leukemia (ALL):
- •Complete first remission (CR1) at high risk for relapse
- •Complete second remission (CR2).
- •Other acute leukemias that are of ambiguous lineage or of other types
- •Any acute leukemia with marrow aplasia or without adequate count recovery.
- •Myelodysplastic Syndrome (MDS)
- •Karnofsky score > 70 %.
- •Calculated creatinine clearance > 60 ml/min.
- •Bilirubin < 1.5 mg/dL, ALT < 3 x upper limit of normal
- •Pulmonary function (FVC, FEV1 and corrected DLCO) > 50% predicted.
- •Left ventricular ejection fraction > 50%.
- •Albumin > 3.0 g/dL.
- •Negative antiviral serology:
- •Negative human immunodeficiency virus (HIV) antibody.
- •Negative human T-lymphotropic virus (HTLV)-1 and 2 antibodies.
- •Negative hepatitis B surface antigen (HBsAg) and undetectable hepatitis B virus (HBV) DNA
- •Negative hepatitis C virus (HCV) antibody or negative HCV ribonucleic acid (RNA)
- •For female subjects of childbearing potential:
- •A negative serum pregnancy test
- •Willing to use contraception throughout the study period.
- •Male subjects must be willing to use a recommended method of contraception throughout the study period, and to refrain from sperm donation throughout the study period.
- •Two appropriate CB units identified for the subject.
- •In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject's cancer.
- •Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.
- •Evidence of a signed informed written consent
排除标准
- •Pregnancy or breastfeeding.
- •Current active, uncontrolled bacterial, viral, or fungal infection
- •Prior allogeneic or autologous HCT at any time.
- •Active malignancy other than the one for which AB-110 transplant is being performed within 12 months of enrollment.
- •Any identified and available 10/10 HLA-matched related donor or 10/10 HLA-matched unrelated donor.
- •Have evidence of recipient donor specific anti-HLA antibodies.
- •Active central nervous system (CNS) disease at time of screening.
- •Documented allergy to DMSO, mouse or bovine proteins, or iron.
- •Subject has other conditions that in the opinion of the investigator would place the subject at increased risk for toxicity by participation in the study.
- •Psychiatric condition making the patient unlikely to comply with protocol therapy, required tests and follow-up.
结局指标
主要结局
Occurrence of adverse events grade 4 or grade 5 as assessed by CTCAEv4
时间窗: 24 hours
Graft failure defined as survival to day 42 without absolute neutrophil count greater than or equal to 500/mm3
时间窗: 42 days
次要结局
- Presence of post-transplant phenotype in hematopoietic cells of donor origin(180 days)
- Cumulative incidence of grade II - IV acute graft versus host disease (aGVHD)(100 days)
- Cumulative incidence of grade II - IV acute graft versus host disease (GVHD)(180 days)
- Time to lymphoid recovery(180 days)
- Cumulative incidence of sustained donor-derived neutrophil engraftment(180 days)
- Disease Free Survival (DFS)(180 days)
- Time to neutrophil engraftment(42 days)
- Incidence of engraftment syndrome(28 days)
- Cumulative incidence of graft failure(180 days)
- Cumulative incidence of chronic GVHD(180 days)
- Cumulative incidence of transplant related mortality (TRM)(180 days)
- Overall survival (OS)(180 days)
研究者
研究点 (6)
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