Clinical Study on the Safety and Effectiveness of CD38 CAR-T Cells in the Treatment of CD38-positive Hematological Malignancies
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
Clinical Study on the Safety and Effectiveness of CD38 CAR-T Cells in the Treatment of CD38-positive Hematological Malignancies
详细描述
The CAR-T cell injection uses immune cells from healthy donors, and is the final product obtained after CAR genetic modification, cell expansion, culture, screening, preparation, sub-packaging, and release inspection. CD38 is highly expressed in myeloid leukemia, and it has been confirmed that the treatment of targeting CD38 has great potential in the treatment of CD38-positive hematological malignancies. The center intends to apply for a clinical trial of CD38 CAR-T cells to treat CD38-positive hematological malignancies on the basis of preliminary research.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients is histologically diagnosed with CD38-positive AML according to the NCCN Clinical Practice Guidelines in Oncology：Acute Myeloid Leukemia（Version 2.2021）;
- •The diagnosis is consistent with r/r CD38 + AML, and includes any of the following conditions:
- •No CR was obtained after 2 courses of standard chemotherapy
- •The first induction was CR, but the duration of CR was less than 12 months
- •No CR was obtained after the first or multiple remedial treatment
- •Relapse twice or more
- •The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1% (flow cytometry);
- •No active lung infection, inhaled air oxygen saturation ≥92%;
- •The estimated survival time is more than 3 months;
- •ECOG score was 0-2;
- •The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
排除标准
- •Patients with history of epilepsy or other central nervous system diseases;
- •Patients with prolonged QT or severe heart disease;
- •Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
- •The patients with uncontrolled active infection;
- •Active hepatitis B or hepatitis C virus infection;
- •Previous application of gene therapy;
- •The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- •Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
- •Those who suffer from other uncontrolled diseases are not suitable to join the study;
- •HIV infection;
- •Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 90 days after CD38 CAR T-cells infusion
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Dose-limiting toxicity (DLT)
时间窗: Baseline up to 28 days after CD38 CAR T-cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
次要结局
- Duration of remission, DOR(24 months post CD38 CAR-T cells infusion)
- Concentration of CAR-T cells(From admission to the end of the follow-up, up to 2 years)
- Overall survival, OS(From CD38 CAR-T infusion to death，up to 2 years)
- Progression-free survival, PFS(24 months post CD38 CAR-Tcells infusion)
- Disease control rate, DCR(From Day 28 CD38 CAR-T infusion up to 2 years)
研究者
He Huang
The President of The First Affiliated Hospital, College of Medicine, Zhejiang University
Zhejiang University