NCT02965157Unknown1 期
Pilot Study of Anti-CD20-CAR-engineered T Cells in Patients With Chemotherapy Resistant or Refractory CD20+ Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- all cause mortality
研究概览
简要总结
Chimeric antigen receptor (CAR) T cells targeting CD20 will be evaluated for safety and efficacy in patients with CD20+ B cell lymphoma. The CAR consists of a CD20 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory CD20+ B-cell lymphoma.
- •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.
- •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.
结局指标
主要结局
all cause mortality
时间窗: one year
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
CAR20.19.22 T-cells in Relapsed, Refractory B-cell MalignanciesB-cell Non Hodgkin LymphomaB-cell Chronic Lymphocytic LeukemiaNCT05094206Medical College of Wisconsin48
Unknown
1 期
A Clinical Research of CD20-Targeted CAR-T in B Cell MalignanciesLymphomaLeukemiaNCT02710149Southwest Hospital, China45
撤回
1 期
CAR-T Cell Immunotherapy for HCC Targeting GPC3GPC3 Positive Hepatocellular CarcinomaCAR-T Cell ImmunotherapyNCT02723942Fuda Cancer Hospital, Guangzhou
Unknown
1 期
Dual Target CAR-T Cells in B-cell LymphomaLymphoma, B-CellRelapse/RecurrenceRefractory LymphomaDual-target CAR-T CellsNCT04723914YuLi20
Unknown
1 期
The Clinical Research of Anti-CD20 CAR-T Cells in Patients With Refractory or Relapsed B Lymphocyte LymphomaRelapsed or Refractory B-cell LymphomasNCT03576807Xin Wang20