NCT04316624已完成1 期
A Study Evaluating Safety and Efficacy of CBM.CD20 CAR-T(C-CAR066) in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年9月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The incidence of adverse events
研究概览
简要总结
This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r DLBCL 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 75 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 18-75 years old, male or female
- •Patients diagnosed with diffuse large B-cell lymphoma (DLBCL, De novo or transformed) histologically according to the 2016 WHO Classification, at least one measurable lesion(LDi≥1.5 cm)
- •r/r DLBCL patients who received prior CD19 CAR-T therapy, and positive for CD20
- •At least 2 weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
- •Adequate organ and bone marrow fuction
- •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 inhibitors
- •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 peripheral blood 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
研究组 & 干预措施
C-CAR066
Experimental
Autologous C-CAR066 (CD20-directed CAR T-cell) administered by intravenous (IV) infusion
干预措施: C-CAR066 (Drug)
结局指标
主要结局
The 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
- Objective response rate (ORR)(Up to 24 months after C-CAR066 infusion)
- Complete response rate (CRR)(Up to 24 months after C-CAR066 infusion)
- Overall survival (OS)(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
Zou Dehui
Chief Physician
Institute of Hematology & Blood Diseases Hospital, China
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of C-CAR066 in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T TherapyB Cell LymphomaNCT04036019Shanghai Tongji Hospital, Tongji University School of Medicine13
Unknown
不适用
C-CAR011 Treatment in Subjects With ALL After HSCTAcute Lymphoblastic Leukemia(ALL)NCT03327285Peking University People's Hospital40
Unknown
1 期
Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple MyelomaRelapsed or Refractory Multiple MyelomaNCT04194931The First Affiliated Hospital of Nanchang University20
已完成
1 期
A PhaseⅠb Study Evaluating Safety and Efficacy of C-CAR011 Treatment in B- NHL SubjectsB-cell Non-Hodgkin LymphomaNCT03483688Peking Union Medical College Hospital6
招募中
1 期
Safety and Efficacy of CD19-BCMA Targeted CAR-T Therapy for Refractory Generalized Myasthenia GravisMyasthenia GravisNCT06371040Ting Chang, MD9