NCT05259813撤回1 期
An Open Label, Single-arm, Phase I Study of JWCAR029 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Shanghai Ming Ju Biotechnology Co., Ltd.1 个研究点 分布在 1 个国家开始时间: 2022年2月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Treatment-related adverse events (AEs)
研究概览
简要总结
This is a Phase I, open-label, single-arm, single center study to assess the safety and efficacy of JWCAR029 in subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
详细描述
Upon the successful product generation of Relmacabtagene Autoleucel, subjects will enter the treatment phase of the study. Treatment will include lymphodepleting chemotherapy followed by Relmacabtagene Autoleucel administration. Subjects will then enter the post-treatment follow-up phase of the study and will be followed for approximately 24 months for safety, disease status, and survival. Long-term follow-up will continue under a separate long-term follow-up protocol, currently up to 15 years after the last Relmacabtagene Autoleucel administration.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old and ≤ 75 years old;
- •Sign on the informed consent;
- •Diagnosis of:
- •CLL with an indication for treatment based on iwCLL 2018 and measurable disease, or
- •SLL (lymphadenopathy and/or splenomegaly and < 5×10^9 CD19+ CD5+ clonal B lymphocytes/L [< 5000/µL] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL);
- •Relapsed/refractory patients, Subjects must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Expected survival is greater than 12 weeks;
- •Adequate organ function;
- •Adequate vascular access for leukapheresis procedure;
- •Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029; Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029.
排除标准
- •Central nervous system (CNS) only involvement by malignancy or primary CNS lymphoma;
- •History of another primary malignancy that has not been in remission for at least 2 years;
- •Subjects has HBV, HCV, HIV or syphilis infection at the time of screening;
- •Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
- •Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
- •Presence of acute or chronic graft-versus-host disease (GVHD);
- •History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
- •Pregnant or nursing women;
- •Subjects using of any chemotherapy, corticosteriod, experiment agents, GVHD therapies, radiation or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
- •Received allo-hematopoietic stem cell transplantation therapy previously.
- •Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
- •Received CAR T-cell or other genetically-modified T-cell therapy previously.
结局指标
主要结局
Treatment-related adverse events (AEs)
时间窗: 2 years
Type, Proportion, and Severity
Recommended dose of JWCAR029
时间窗: 28 days after JWCAR029 infusion
Recommended dose of JWCAR029
次要结局
- Objective response rate (ORR)(3 months)
- Best Objective response (BOR) rate(3 months)
- Pharmacokinetics- Time of the maximum concentration (Tmax)(2 years)
- Complete response rate (CRR)(3 months)
- MRD-negative response rate(3 months)
- Pharmacokinetics- area under the curve(2 years)
- Pharmacokinetics- Maximum concentration (Cmax)(2 years)
- Best Complete response (CR) rate(3 months)
- Progression free survival (PFS)(2 years)
- Overall survival (OS)(2 years)
- Duration of response(2 years)
- Serum cytokines associated with CRS(2 years)
研究者
研究点 (1)
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