NCT05480501招募中早期 1 期
Clinical Trial to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia
Beijing Immunochina Medical Science & Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2022年7月11日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This is a open-label to assess the efficacy and safety of IM19 CAR-T cells in R/R B-cell Acute Lymphoblastic Leukemia.
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
- 3 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory B-ALL, defined as：1）Not chieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia. 2）Any relapse after HSCT and must be ≥ 6 months from HSCT at the time of IM19 CAR-T cells infusion. 3）Primary refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen.
- •Patients with Ph+ ALL are eligible if they are intolerant to or have failed two lines of TKI ± chemotherapy ；Ph + all patients with T315I mutation are not required to receive at least two TKI ± chemotherapy in the absence of effective TKI therapy.
- •Morphological evidence of disease in bone marrow (at least 5% blasts).
- •Aged 3 to 70 years.
- •Estimated life expectancy >3 months.
- •ECOG performance status of 0 or 1(age ≥ 16 years) or Lansky (age < 16 years).
- •Women of childbearing age who had a negative blood pregnancy test before the start of the trial and agreed to take effective contraceptive measures during the trial period until the last follow-up; male subjects with fertility partners agreed to take effective contraceptive measures during the trial period until the last follow-up.
- •Adequate organ function.
- •Volunteer to participate in this trial and sign on the informed consent.
排除标准
- •Subjects with lsolated extramedullary disease relapse.
- •Subjects with Burkitt's lymphoma.
- •Subjects has obvious symptoms of central nervous system invasion and needs targeted treatment.
- •Subjects has previously received gene product therapy.
- •Subjects has graft-versus-host response（GVHD） and need to use immunosuppressants or GVHD ≥ grade 2 or being treated with anti GVHD or suffering from autoimmune diseases.
- •Subjects has received chemotherapy or radiotherapy within 3 days before leukapheresis.
- •Subjects received systemic steroids within 5 days prior to leukapheresis.
- •Subjects received drugs that stimulated the production of hematopoietic cells in the bone marrow for 5 days prior to leucapheresis.
- •Subjects has participated in other clinical studies within 1 month before screening or plan to participate in other drug clinical trials during this study.
- •Subjects received allogeneic cell therapy within 6 weeks before leukapheresis.
- •Subjects with History or presence of CNS disorder.
- •Subjects with HBV, HCV, HIV ,EBV,ECV or syphilis infection at the time of screening.
- •Pregnant or lactating, or planning pregnancy within 180 days after the end of CAR-T cells infusion, or male patients whose partners plan pregnancy 180 days after their CAR-T cell infusion.
- •Subjects with other tumors in the past 5 years.
- •Within 14 days before enrollment, there were active or uncontrollable infections requiring systemic treatment.
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: Up to 28 days after CAR-T cell infusion
Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood and bone marrow )
时间窗: Up to 24 weeks after CAR-T cell infusion
次要结局
- Objective response rate (ORR)(Up to 24 weeks after CAR-T cell infusion)
- Relapse free surviva（PFS）(Up to 24 weeks after CAR-T cell infusion)
- Duration of Response (DOR)(Up to 24 weeks after CAR-T cell infusion)
- Overall survival (OS)(Up to 24 weeks after CAR-T cell infusion)
- Minimal residual disease（MRD）(Up to 24 weeks after CAR-T cell infusion)
研究者
研究点 (1)
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