NCT06210243终止1 期
A Single-arm, Open-label Clinical Study to Assess the Safety and Efficacy of the C752 CAR-T Cells for Patients With CD19+ Refractory/Relapsed B Cell Non-Hodgkin Lymphoma
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2023年12月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicities
研究概览
简要总结
It is a single-arm, open-label clinical study to assess the safety and efficacy of the C752 CAR-T Cells for patients with CD19+ refractory/relapsed 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
- •Written informed consent in accordance with federal, local, and institutional guidelines, Males and females ≥18 years of age at the time of consent
- •Documented diagnosis of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
- •Have progression by least one systemic treatment and no available standard of care treatment.
- •At least one measurable lesion by Lugano 2014
- •Expected survival ≥ 12 weeks
- •Have an ECOG performance status of 0 or 1
- •Adequate organ function
- •Screening test indicates histopathological CD19 + if the subject received CD19-targeted therapy
- •Women of childbearing age must have a negative pregnancy test, and agree to take effective contraception during the trial
排除标准
- •Treatment with any prior HSCT, gene therapy product, cell therapy product ect.
- •Central nervous system involvement
- •HIV infection
- •Concurrent use of systemic steroids or immunosuppression
- •Uncontrolled active infection
- •Wash-out period of from the last anti-cancer treatment
- •Active second malignancy
- •Have not recovered from the effects of previous therapy
- •Have psychological or physical conditions that do not permit compliance with the protocol
- •Pregnant or nursing (lactating) women
研究组 & 干预措施
C752
Experimental
干预措施: C752 (Biological)
结局指标
主要结局
Dose Limiting Toxicities
时间窗: First 28 days s after C752 injection
The incidence and severity of adverse events (AEs)
时间窗: 1 year
次要结局
- Objective response rate (ORR)(1 year)
- Pharmacokinetic - AUC(1 year)
- PFS(1 year)
研究者
研究点 (1)
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