CD19-targeting, 3rd Generation CAR T Cells for Refractory B Cells Malignancy - a Phase II Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
Treatment of patients with B cell lymphoma or leukemia with two doses of CD19-targeting chimeric antigen receptor (CAR) T cells to evaluate for safety and efficacy.
详细描述
Treatment of patients with B cell lymphoma or leukemia with two doses of CD19-targeting chimeric antigen receptor (CAR) T cells to evaluate for safety and efficacy. 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 the second infusion patients will be subjected to immunomodulatory treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
Primary outcome:
- Registration of the safety profile such as inflammation, fever, pain, changes in blood pressure, pulse and other adverse events.
Weekly for the first 6 weeks, then at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Secondary outcome:
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
- 0 Years 至 100 Years（Child, 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 with no other curative treatment option available.
- •Measurable disease.
- •Performance status ECOG 0-
- •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 to perform the treatment.
- •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
- •Patients whose cells cannot be manufactured.
结局指标
主要结局
Safety
时间窗: 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
次要结局
- CAR T cell persistence(24 months)
- B cell levels(24 months)
- Immunological profile(24 months)
- Tumor response(24 months.)
- Cytokine profile(24 months)