Phase I Study of T Cells Expressing an Anti-CD22 Chimeric Receptor in Children and Young Adults With B Cell Malignancies
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 主要终点
- Adverse events of each patient
研究概览
简要总结
This study aims to evaluate the safety, efficacy and duration of response of CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD22+ 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 CD22 Chimeric Antigen Receptor (CAR) T-cells (CD22 CAR T-cells) in patients with high risk, relapsed CD22+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD22 CAR Tcells. Patients will receive the CD22CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD22 CAR T-cells in patients with high risk relapsed CD22+ malignancies
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 70 Years（Child, 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 2 years to 70 years.
- •CD22 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
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
Adverse events of each patient
时间窗: 3 years
Determine the toxicity profile of the CD22 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
Maximum tolerated dose (MTD) of CD22 targeted CAR T cells.
时间窗: 4 weeks
Maximum tolerated dose (MTD) of CD22 targeted CAR T cells.
Survival time of Anti-CD22 CAR T cells in vivo
时间窗: 3 years
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
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
未报告次要终点