EUCTR2015-005176-17-IT进行中（未招募）1 期
A Phase I Study of Safety, Pharmacokinetics and Efficacy of Donor BPX-501 Cells and AP1903 Infusion for Children with Recurrent or Minimal Residual Disease Hematologic Malignancies After Allogeneic Transplant - Cninical Trial BP-I-008
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Recipient inclusion criteria:
- •1.Subjects aged >1yrs and < 18yrs
- •2.Clinical diagnosis of one of the following pediatric hematological malignancies:
- •b)Myelodysplastic Syndromes
- •c)Lymphomas
- •d)Other high-risk hematological malignancy eligible for stem cell transplantation per institutional standard
- •3.Recurrent disease that presents >100 days after, or minimal residual disease (MRD) that presents > 30 days after either:
- •a)Matched related HSCT
- •b)Mismatched related HSCT
- •4.Life expectancy >10 weeks;
- •5.Signed donor and patient/guardian informed consent;
- •6.A minimum genotypic identical match of 4/8 is required, as determined by high resolution typing for at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA- DRB1.
- •7. Performance status: Karnofsky/Lanksy score > 50%.
- •8.Subjects with adequate organ function as measured by:
- •a.Bone marrow:
- •· >25% donor T-cell chimerism
- •· ANC>1 x 109/L.
- •b.Cardiac: LVEF at rest >45%.
- •c.Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) > 50% predicted (corrected for hemoglobin); for children who are unable to perform pulmonary function tests due to age or developmental ability, there must be no evidence of dyspnea or no need for supplemental oxygen as evidenced by 02 saturation = 92% on room air.
- •d.Hepatic: direct bilirubin = 3x upper limit of normal (ULN), or AST/ALT = 5x ULN.
- •e.Renal: creatinine clearance = 2x of ULN for age
- •1. Donor must have been the donor of the prior allogeneic peripheral
- •blood stem cell (PBSC) or bone marrow (BMSC) transplant:
- •a. Matched related HSCT
- •b. Mismatched related HSCT
- •2. Donor age must be = 18 and = 60 years.
- •a. The donor should be sufficiently healthy not to be at increased risk
- •from the leukapheresis procedure.
- •3. Donors must meet the selection criteria as defined by the European
- •Directive 2006/17/CE and per the local regulations for donor selection.
- •4. The donor must have been informed of the investigational nature of
- •the BPX-501 product and have signed an informed consent form.
- •5. Donor must have adequate peripheral venous access for leukapheresis or must agree to placement of a central venous catheter.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.= Grade II acute GvHD or chronic extensive GvHD due to a previous
- •allograft at the time of screening;
- •2.Active CNS involvement by malignant cells (less than 2 months from
- •the conditioning);
- •3.Current uncontrolled bacterial, viral or fungal infection (currently
- •taking medication with evidence of progression of clinical symptoms or
- •radiologic findings).
- •4.Positive HIV serology or viral RNA (= Grade III per CTCAE criteria);
- •5.Pregnancy (positive serum ßHCG test) or breast-feeding female;
- •6.Fertile men or women unwilling to use effective forms of birth control
- •or abstinence for a year after BPX-501 T cell infusion;
- •7.Bovine product allergy.
- •Donor Exclusion Criteria:
- •1. Evidence of active infection (including urinary tract infection, or upper respiratory tract infection) or viral hepatitis exposure (on screening), unless HBs Ab+ and HBV DNA negative.
- •2. Factors which place the donor at increased risk for complications from leukapheresis (e.g., autoimmune disease, symptomatic coronary artery disease requiring therapy, previous thrombotic events).
- •3. Pregnancy (positive serum or urine ßHCG) or breastfeeding female
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