NCT04718883进行中（未招募）2 期
A Phase II Open-Label, Single-Arm, Multicenter Study of JWCAR029, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma
Shanghai Ming Ju Biotechnology Co., Ltd.12 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2021年1月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 59
- 试验地点
- 12
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a phase II, open-label, single-arm, multicenter study to assess the efficacy and safety of JWCAR029 in adult R/R Mantle Cell Lymphoma subjects in China.
详细描述
This is a phase II, open-label, single-arm, multicenter study conducted in adult subjects with relapsed and refractory (R/R) mantle cell lymphoma (MCL) in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and immune response after JWCAR029 treatment.
R/R MCL patients will be enrolled in dose level of 1.0 x 10^8 CAR+ T cells. All subjects will be followed for 5 years following JWCAR029 infusion.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old;
- •Sign on the informed consent;
- •Subject must have histologically confirmed mantle cell lymphoma;
- •Relapsed/refractory patients;
- •Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
- •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;
- •Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
- •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
Objective response rate (ORR)
时间窗: 3 months
Objective response rate (ORR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects
次要结局
- Cmax of JWCAR029(Up to 1 year after JWCAR029 infusion)
- Type of adverse events (AEs)(Up to 24 months after JWCAR029 infusion)
- Duration of complete remission (DoCR)(Up to 24 months after JWCAR029 infusion)
- Changes of serum cytokines(Up to 2 year after JWCAR029 infusion)
- The best objective response rate(3 months)
- Duration of partial remission (DoPR)(Up to 24 months after JWCAR029 infusion)
- Time to complete response (TTCR)(Up to 24 months after JWCAR029 infusion)
- Overall survival (OS)(Up to 5 year after JWCAR029 infusion)
- The best complete response rate(3 months)
- Severity of adverse events(AEs)(Up to 24 months after JWCAR029 infusion)
- Severity of laboratory abnormalities(Up to 24 months after JWCAR029 infusion)
- Time to response (TTR)(Up to 24 months after JWCAR029 infusion)
- Progression-free survival (PFS)(Up to 2 year after JWCAR029 infusion)
- CD19 expression in tumor biopsy samples(Up to 2 year after JWCAR029 infusion)
- Number of participants with adverse events (AEs)(Up to 24 months after JWCAR029 infusion)
- Type of laboratory abnormalities(Up to 24 months after JWCAR029 infusion)
- Duration of response (DOR)(Up to 24 months after JWCAR029 infusion)
- Tmax of JWCAR029:(Up to 1 year after JWCAR029 infusion)
- AUC of JWCAR029:(Up to 1 year after JWCAR029 infusion)
- Changes of Subgroups of T cell(Up to 2 year after JWCAR029 infusion)
- Complete response rate (CRR)(3 months)
- Number of participants with laboratory abnormalities(Up to 24 months after JWCAR029 infusion)
- Anti-therapeutic JWCAR029 antibody(Up to 2 year after JWCAR029 infusion)
- Changes of T cell counts(Up to 2 year after JWCAR029 infusion)
- Changes in inflammatory biomarkers such as CRP(Up to 2 year after JWCAR029 infusion)
- Changes in inflammatory biomarkers such as ferritin(Up to 2 year after JWCAR029 infusion)
研究者
研究点 (12)
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