NCT04036019已完成1 期
A Study Evaluating Safety and Efficacy of CBM.CD20 CAR-T(C-CAR066) in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy
Shanghai Tongji Hospital, Tongji University School of Medicine1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2019年8月20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
- 13
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This is a single-center, non-randomized clinical study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r B cell lymphoma who received CD19 CAR-T therapy.
详细描述
This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066. Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection.
The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient volunteered to participate in the study, and signed the Informed Consent
- •Age 18-70 years old, male or female
- •Patients with CD20+ DLBCL (including PMBCL and tFL), FL and MCL, at least one measurable lesion (LDi≥ 1.5 cm)
- •r/r lymphoma patients who received prior CD19 CAR-T therapy
- •At least one week from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
- •No immunosuppressive therapy was used within 1 week before C-CAR066 infusion
- •No mAb treatment within 2 weeks before C-CAR066 infusion
- •Adequate organ and bone marrow function
- •No contraindications of apheresis
- •Expected survival time > 3 months
- •ECOG scores 0-1
排除标准
- •Have a history of allergy to cellular products
- •Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard
- •A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease
- •Patients with active CNS involvement
- •Patients with autoimmune disease, immunodeficiency, or other treatment requiring immunosuppressor
- •Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed
- •Live vaccination within 4 weeks before apheresis
- •HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers
- •Have a history of alcoholism, drug addiction and mental illness
- •Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception
- •Patients with severe fludarabine or cyclophosphamide hypersensitivity
- •The patient has a history of other primary cancers, except for the following:
- •Non-melanoma such as skin basal cell carcinoma cured by resection
- •Cured carcinoma in situ such as cervical, bladder or breast cancer
- •The investigators believe that there are other circumstances that are not suitable for the trial
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 12 weeks after C-CAR066 infusion
The incidence of treatment-emergent adverse events (TEAEs)
次要结局
- Complete response rate (CRR)(Up to 24 months after C-CAR066 infusion)
- Overall survival (OS)(Up to 24 months after C-CAR066 infusion)
- Objective response rate (ORR)(Up to 24 months after C-CAR066 infusion)
- Duration of response (DOR)(Up to 24 months after C-CAR066 infusion)
- Progression free survival (PFS)(Up to 24 months after C-CAR066 infusion)
研究者
Aibin Liang，MD，Ph.D.
Director，Department of Hematology
Shanghai Tongji Hospital, Tongji University School of Medicine
研究点 (1)
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