A Study to Evaluate the Safety and Clinical Activity of Allogeneic Chimeric Antigen Receptor T Cells Targeting CD19 in Patients With Refractory or Relapsed B Cell Malignancies.
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Complete Remission
研究概览
简要总结
This is a study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell malignancies.
详细描述
This is a single-center, nonrandomized, open-label study to evaluate the safety and clinical activity of ThisCART19 in patients with refractory or relapsed CD19 positive B cell malignancies, such as acute or chronic lymphocytic leukemia, lymphoma and etc. The dose range is 0.2-60 x 10^6 cells per kg body weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with relapsed or refractory CD19 positive acute or chronic lymphocytic leukemia, or lymphoma.
- •No alternative treatment options deemed by investigator.
- •Measurable or detectble disease at time of enrollment.
- •Eastern cooperative oncology group (ECOG) performance status of ≤
- •Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO).
- •Estimated life expectancy > 12 weeks deemed by investigator.
- •Serum creatinine ≤1.6 mg/dl and/or blood urea nitrogen(BUN) ≤ 1.5 mg/dl .
- •Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 upper limit of normal (ULN).
- •Informed consent explained to, understood by and signed by patient/guardian.
排除标准
- •Pregnant or lactating women
- •Uncontrolled infection
- •Active hepatitis B virus or hepatitis C virus infection.
- •Patients who need steroids to control disease.
- •Patients who accepted autologous stem-cell transplantation (ASCT) within 100 days.
- •Patients with grade 2-4 graft-versus-host disease (GVHD), or deemed need to manage by investigator.
- •History of Human Immunodeficiency Virus (HIV) infection.
- •Patients with active central nervous system (CNS) involvement by malignancy.
- •Patients combine with other disease cause neutrophil count (ANC) < 750 per microlitre or platelet count (PLT)< 50,000 per microlitre.
结局指标
主要结局
Complete Remission
时间窗: At Day 28 after ThisCART19 infusion
Proportion of patients in whom with morphologic complete remission (CR)
TRM: Treatment Related Mortality
时间窗: Up to 2 years
The mortality related with ThisCART19 infusion.
Incidence of Dose Limiting Toxicities
时间窗: From infusion to Day 28
To assess adverse events as dose limiting toxicities as defined by the protocol.
次要结局
- Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability(From inclusion up to 1 year)
- Objective Response Rate(Up to 1 year)
- Overall Survival Rate of 2 Years(At year 2)
- Duration of Response(Up to 1 year)