NCT03355859Unknown1 期
A Phase 1, Open-Label Study of JWCAR029, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Adult Subjects With Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL)
Zhao Weili1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年1月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Treatment-related adverse events (AEs)
研究概览
简要总结
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of autologous CD19-targeted chimeric antigen receptor (CD19 CAR) T cells in adult patients with relapsed and refractory B-cell Non-Hodgkin lymphoma.
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
- •Subjects must meet all of the following criteria to be enrolled in this study:
- •Age ≥ 18 years at the time of consent
- •Signed written informed consent obtained prior to any study procedures
- •Relapsed or refractory B-cell NHL.
- •PET-positive disease BY Lugano classification
- •Archived tumor biopsy tissue available from the last relapse and corresponding pathology report available or, if at least one tumor-involved site is deemed accessible at time of screening, willing to undergo pre-treatment biopsy (excisional when possible) for disease confirmation. If a subject has never had a complete response, a sample from the most recent biopsy is acceptable.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate bone marrow, renal, hepatic, pulmonary and cardiac function
- •Adequate vascular access for leukapheresis procedure
- •Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy
- •Subjects must agree to use appropriate contraception.
排除标准
- •Subjects who meet any of the following criteria will be excluded from participation in this study:
- •Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
- •History of another primary malignancy that has not been in remission for at least 2 years.
- •Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis
- •Active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at the time of screening
- •Subjects with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or JWCAR029 administration
- •Presence of acute or chronic graft-versus-host disease (GVHD)
- •History of cardiovascular disease
- •History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
- •Pregnant or nursing women.
- •Prior CAR T-cell or other genetically-modified T-cell therapy, with the exception of prior JWCAR029 treatment in this protocol for subjects receiving retreatment
研究组 & 干预措施
JWCAR029
Experimental
The safety and efficacy of JWCAR029 will be evaluated in a standard 3+3 dose escalation approach. 4 CAR T dosage will be tested in this study: 1×10^7, 2.5×10^7, 5×10^7, 1×10^8 CAR+ T cells.
干预措施: JWCAR029 (Biological)
结局指标
主要结局
Treatment-related adverse events (AEs)
时间窗: 2 years
Physiological parameter
Dose-limiting toxicities of JWCAR029
时间窗: 28 days after JWCAR029 infusion
Physiological parameter
Objective response rate (ORR)
时间窗: 2 years
Lugano criteria
次要结局
- Time to maximum concentration (Tmax) of JWCAR029 in the peripheral blood and bone marrow(1 year after JWCAR029 infusion)
- Maximum concentration (Cmax) of JWCAR029 in the peripheral blood and bone marrow(1 year after JWCAR029 infusion)
- Complete response (CR) rate(2 years)
- Progression-free survival (PFS) and PFS ratio(2 years)
- Area-under the concentration-vs-time-curve (AUC) of JWCAR029 in the peripheral blood and bone marrow(1 year after JWCAR029 infusion)
- Overall survival(2 years)
- Duration of response(2 years)
- Health-related quality of life (HRQoL)(2 years)
研究者
Zhao Weili
Professor
Ruijin Hospital
研究点 (1)
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