Phase I Study of T Cells Expressing an Anti-CD19 and Anti-CD20 Bispecific Chimeric Receptor in Patients With B Cell Malignancies
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Antitumor Effects
研究概览
简要总结
This study aims to evaluate the safety, efficacy and duration of response of anti-CD19 anti-CD20 Bispecific Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ and CD20+ haematological malignancies.
详细描述
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 CD20 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ and CD20+haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CD20 CAR T-cells. Patients will receive the CD19 CD20 CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CD20 CAR T-cells in patients with high risk relapsed CD19+ malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
- •Life expectancy>3 months.
- •Gender unlimited, age from 18 years to 70 years.
- •CD19 or CD20 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
- •Patients who have failed at least one line of a standard treatment.
- •No serious mental disorder.
- •Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
- •No other serious diseases(autoimmune disease, immunodeficiency etc.).
- •No other tumors.
- •Patients volunteer to participate in the research.
- •Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial.
排除标准
- •Patients are allergic to cytokines.
- •Central nervous system leukemia within 28 days.
- •Uncontrolled active infection.
- •Acute or chronic GVHD.
- •Treated with T cell inhibitor.
- •Pregnancy and nursing females.
- •HIV/HBV/HCV Infection.
- •Other situations we think improper for the research.
结局指标
主要结局
Antitumor Effects
时间窗: Every 3 months post treatment up to 24 months
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
次要结局
- Survival time of Anti-CD19 Anti-CD20 CAR T cells in vivo.(3 years)
- Adverse events of each patient.(3 years)