NCT07248163招募中不适用
A Clinical Study of the Safety and Efficacy of Universal CAR-T Cells Targeting CD19 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma
Bioray Laboratories1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2025年3月11日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
This is a single-center, single-arm, open-label clinical study, and the sample size is set to 3-6 subjects.
详细描述
This is a single-center, single-arm, open-label clinical study, and the sample size is set to 3-6 subjects. Evaluating the safety, tolerability, and efficacy of BRL-301 at a dose level of 5E6/kg.
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
- •Willing to participate in this clinical study and sign an informed consent form;
- •Age ≥ 18 years old;
- •Estimated survival time ≥ 3 months;
- •At least one measurable lesion;
- •CD19 positively expressed;
- •ECOG score 0-1；
- •Hematology, coagulation and biochemistry parameters meeting the requirements;
- •LVEF ≥ 55%;
- •No severe pulmonary disorders;
排除标准
- •Pregnant or lactating women;
- •Subjects who previously received allogeneic cell therapies, including allogeneic stem cell transplant;
- •Subjects who previously received anti-CD19 targeted therapy;
- •Prior treatment with any CAR-T cell product or other genetically modified T cell therapies;
- •History of Richter's transformation of chronic lymphocytic leukemia (CLL);
- •Presence of uncontrollable fungal, bacterial, viral, or other infections requiring systemic therapy;
- •Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;
- •Severe mental disorders; history of CNS disorders (e.g., epileptic seizure, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any CNS-involved autoimmune disorders);
- •Active autoimmune disorders requiring immunotherapy, including but not limited to end organ damages caused by autoimmune disorders (e.g., Crohn's disease, rheumatoid arthritis, and systemic lupus erythematosus) in the past 2 years, or requiring systemic application of immunosuppressive drugs or other drugs for systemic control of diseases;
- •Primary immunodeficiency;
- •History of other malignancies;
- •Patients with severe cardiovascular disorders;
- •Any circumstances that possibly increase the risk of subjects or interfere with the study results as judged by the investigator.
研究组 & 干预措施
Treatment group
Experimental
5×10^6/kgBW
干预措施: BRL-301 (Drug)
结局指标
主要结局
DLT
时间窗: Within 28 Days After BRL-301 Infusion
The number and severity of dose-limiting toxicity (DLT) events
次要结局
未报告次要终点
研究者
研究点 (1)
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