NCT04812691已完成1 期
CD19-targeted CAR T Cells （JWCAR029） for Primary Refractory Diffuse Large B Cell Lymphoma, Phase Ⅰ,Open-label,Single-arm,Muticenter Study
Shanghai Ming Ju Biotechnology Co., Ltd.2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年7月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Types, frequency, and severity of adverse events and laboratory anomalies
研究概览
简要总结
This is a phase I, open-label, single-arm, multicenter study to assess the safety and efficacy of JWCAR029 in adult primary refractory DLBCL subjects in China
详细描述
This is a phase I, open-label, single-arm, multicenter study conducted in adult subjects with primary refractory DLBCL in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and collect immune response after JWCAR029 treatment.
One dose level of 1.0 x 10^8 CAR+ T cells is adopted in this study. All sujects will be followed for 2 years after 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 diffuse large B lymphoma and primary refractory with first-line therapy;
- •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;
- •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
- •Subjects who have received second-line treatment or above
- •CD19 negative
- •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, corticisteriod, experiment agents, GVHD therapies, radiation, allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
- •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
Types, frequency, and severity of adverse events and laboratory anomalies
时间窗: 2 years
Physiological parameter
次要结局
- Complete response rate (CRR) in primary refractory DLBCL subjects(1 month)
- Duration of response (DOR)(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)
- Best objective response rate (BORR)(2 years)
- Pharmacokinetic (PK)- AUC of JWCAR029(up to 1 year after JWCAR029 infusion)
- Objective response rate (ORR) in primary refractory DLBCL subjects(1 month)
- Investigator evaluated ORR (ORR=CR+PR)(3 months)
- Duration of complete remission (DoCR)(up to 24 months after JWCAR029 infusion)
- Pharmacokinetic (PK)- Cmax of JWCAR029(up to 1 year after JWCAR029 infusion)
- Pharmacokinetic (PK)- Tmax of JWCAR029(up to 1 year after JWCAR029 infusion)
- Changes of CRP and serum ferritin(1 year after JWCAR029 infusion)
- The concentration of CD19 in tumor biopsy samples(up to 2 year after JWCAR029 infusion)
- The change of serum cytokines concentration(up to 2 year after JWCAR029 infusion)
- Anti-therapeutic JWCAR029 antibody(up to 2 year after JWCAR029 infusion)
- Investigator evaluated CRR(3 months)
- Time to complete response (TTCR)(up to 24 months after JWCAR029 infusion)
- Overall survival (OS)(up to 2 year after JWCAR029 infusion)
- The concentration of Car-T cell(up to 2 year after JWCAR029 infusion)
- The proportion of Car-T cell subgroups(up to 2 year after JWCAR029 infusion)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
1 期
CD19-targeting CAR T Cells in Relapsed or Refractory CD19 Positive B-cell MalignanciesB-cell MalignancyB-Cell Acute Lymphoblastic LeukaemiaB-cell LymphomaNCT03559439Shanghai Tong Ren Hospital9
进行中（未招募）
1 期
CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic LeukemiaAcute Lymphoblastic Leukemia, Adult B-CellNCT03984968The First Affiliated Hospital of Soochow University40
Unknown
1 期
Study Evaluating the Safety and Efficacy of JWCAR029 in Adult Subjects With Relapsed and Refractory B-cell Non-Hodgkin LymphomaNon Hodgkin LymphomaNCT03344367Peking University20
Unknown
1 期
Study Evaluating the Safety and Efficacy of JWCAR029 in Adult Subjects With Relapsed and Refractory B-cell Non-Hodgkin LymphomaNon Hodgkin LymphomaNCT03355859Zhao Weili10
招募中
1 期
Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALLRelapse/Refractory B-cell Acute Lymphoblastic LeukemiaNCT06635330Kara Yakhteh Tajhiz Azma Company5