A Single-arm, Open-label Phase I Study of CAR-T-19 (Anti CD19 scFv Chimeric Antigen Receptor T) Cells for Patients With CD19-positive Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia Under The Age of 25
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
This is a single-arm, open-label phase I study to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19 cells for patients with CD19+ relapse/refractory B-ALL under the age of 25.
详细描述
B-cell acute lymphoblastic leukemia (B-ALL) accounting for 85% of all ALL cases, is a common hematological malignancy in children and adults. CD19 is a widely expressed antigen in both normal B cells and B cells-derived leukemia and lymphomas. This is a single-arm, open-label phase I study of CAR-T-19 (anti CD19 scFv chimeric antigen receptor T) cells for patients with CD19-positive relapse/refractory B-ALL under the age of 25.
Primary endpoint is to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19. Secondary endpoints measure ORR, OS and others.
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
- — 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with relapse/refractory B-ALL.
- •Tumor cells from bone marrow or peripheral blood are measured CD19+ with 3 months before enrollment.
- •Karnofsky Score ≥ 70 or Lansky Score ≥
- •Patients who have a life expectancy of at least 12 weeks.
- •Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures.
排除标准
- •Patients with extramedullary relapse (EMR).
- •Patients with genetic diseases, Burkitt lymphoma and leukemia or other malignancies.
- •Patients positive for any of the following: HbsAg, HBV-DNA, HCV-Ab, HCV-RNA, HIV-Ab, TP-Ab, EBV-DNA or CMV-DNA.
- •Patients with other uncontrolled infection.
- •Patients who received anti-CD19 / anti-CD3 therapy, or any other anti-CD19 therapy.
- •Patients with active Grade II-IV GVHD within 3 months prior to screening.
- •Tumor cells are detected in cerebrospinal fluid.
- •Patients who received HSCT within 3 months prior to screening.
- •Anticipated other clinical trials within 4 weeks before this trial
- •Pregnant or lactating women.
- •Any condition that would, in the investigator's judgment, make it unsuitable for the donors to be enrolled.
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: up to 2 years
DLT within 28 days (±3 days) after CAR-T-19 infusion.
Maximum tolerated dose (MTD)
时间窗: up to 2 years
The maximum dose of DLT occurred in ≤1/6 of the subjects within 28 days (±3 days) after CAR-T-19 infusion.
Adverse events
时间窗: up to 2 years
Percentage of subjects with adverse events.
次要结局
- Overall survival (OS)(up to 2 years)
- Overall recovery rate (ORR)(up to 2 years)
- MRD-Negative Rate(up to 2 years)
- Duration of Response (DOR)(up to 2 years)
- Progression-free Survival (PFS)(up to 2 years)
研究者
Daihong Liu
Director
Chinese PLA General Hospital