NCT06927466招募中1 期
A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.
Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.8 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2024年9月19日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 8
- 主要终点
- (一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.
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
- 3 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form；
- •Meet the diagnostic criteria for recurrent or refractory acute B cell lymphoblastic leukemia；
- •Documentation of CD19/CD22 tumor expression
- •3. Liver, kidney, lung and heart function meet requirements;
- •Expected survival >3 months;
- •Women of childbearing age and all post-adolescent male participants are willing to use highly effective contraceptive methods within 1 year after the infusion of B019 injection. At the same time, the subject should promise not to donate eggs or sperm for assisted reproduction for 1 year after the cell infusion.
排除标准
- •Active CNS involvement by malignancy；
- •Isolated extramedullary leukemia recurrence；
- •Subjects with ≥grade 2 acute or moderate to severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to screening;
- •Has had treatment with any prior CAR-T therapy or other therapy abandoned in protocal.
- •4. Subjects who received therapy abandoned in protocal before PBMC (peripheral blood mononuclear cells) collection or before B019 injection; 5.Active other malignancy in 5 years.
- •Subjects who are positive for any of HBsAg, HBeAg, HBeAb, HBcAb, HCV-RNA, HIV EBV DNA, CMV DNA, HTLV-ab.
- •7. Other situations deemed inappropriate for participation in this study by the investigator.
研究组 & 干预措施
B019
Experimental
干预措施: B019 (Biological)
结局指标
主要结局
(一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Approximately 2 years
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
次要结局
- The overall response rate (ORR)(3 months)
- Overall Survival (OS)(Approximately 2 years)
- PK(Pharmacokinetics):Tmax(Approximately 2 years)
- PK(Pharmacokinetics):Cmax(Approximately 2 years)
研究者
研究点 (8)
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