CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- CAR T cell persistence
研究概览
简要总结
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory CD19+ B-cell lymphoma or leukemia.
- •Measurable disease.
- •Performance status ECOG 0-
- •>18 years old.
- •Fertile females/males must consent to use contraceptives during participation of the trial.
- •Signed informed consent.
排除标准
- •Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
- •Patients with primary CNS lymphoma.
- •Known human immunodeficiency virus (HIV) infection.
- •Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
- •Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
- •Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.
- •Patients that do not consent to that tissue and blood samples are stored in a biobank.
- •Pregnancy
研究组 & 干预措施
CAR T cells
Autologous 3rd generation CD19-targeting CAR T cells
干预措施: Autologous 3rd generation CD19-targeting CAR T cells (Biological)
结局指标
主要结局
CAR T cell persistence
时间窗: At week 1 and 5, there after every 3 months post treatment up to 24 months
Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood.
次要结局
- Tumor load(Every 3 months post treatment up to 24 months)