Phase I Study of the Safety and Efficacy of CD19-CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective Response Rate, ORR
研究概览
简要总结
This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of autologous or donor-derived allogeneic T cells expressing CD19 chimeric antigen receptors (referred to as "CD19-CAR-T cells") in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
详细描述
Primary objective:
To investigate the safety and efficacy of autologous or HLA-haploidentical Allo-CD19-CAR-T cells in the treatment of patients with relapsed or refractory acute B-cell lymphoblastic leukemia.
Secondary objective:
To Assess the patient's quality of life after receiving the treatment.
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
- 3 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obtain Informed Consent Form (ICF) voluntarily signed by the patient;
- •Age 3-70 years old;
- •Primary resistant or relapsed B-cell line acute lymphoblastic leukemia;
- •B cells are positive for CD19 expression;
- •Peripheral blood tumor cell load <50%;
- •KPS score >50 points;
- •7. Normal liver and kidney function;
- •Normal heart function;
- •Good follow-up compliance;
- •Women of childbearing age (15-49 years old) must have a pregnancy test within 7 days before treatment and have a negative result; Men and women with fertility should agree to use effective contraception to ensure that during the study period and following 3 months after treatment the women will not get pregnant.
排除标准
- •Patients with non-B cell acute leukemia;
- •Organ failure: Heart: Grade III and IV Liver: Class C with Child-Turcotte liver function classification Kidney: Renal failure and uremia Lung: severe respiratory failure Brain: Disabilities
- •Active infection;
- •Human immunodeficiency virus (HIV) positive;
- •Acute and chronic graft-versus-host disease (GVHD)> Level 1；
- •Pregnant or lactating women;
- •Patients do not agree to use effective contraception during the treatment period and following 3 months;
- •Patients who participated in other clinical studies at the same time;
- •The researcher believes that there are other factors that are not suitable for inclusion in or influence the subject's participation in or completion of the study;
- •Long-term use greater doses of hormones than physiological doses.
结局指标
主要结局
Objective Response Rate, ORR
时间窗: Up to Day90 after the CD19-CAR-T cell infusion
The percentage of participants who achieved complete remission (CR) over all participants (CRR). The percentage of participants who achieved partial remission (PR) over all participants (PRR).
次要结局
- The amount of CAR-T cells remaining in vivo(2 years after cell infusion.)
- The lifetime of CAR-T cells remaining in vivo(2 years after cell infusion.)