A Single-arm, Open-label, Phase I/II Clinical Study of GT719 Injection for Recurrent/Refractory CD19 Positive Adult B-cell Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events per CTCAE 5.0
研究概览
简要总结
This study is a prospective single-arm open-labled phase I/II clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in relapsed/refractory CD19 positive adult B-cell non Hodgkin lymphoma (B-NHL) and B-acute lymphoblastic leukemia (B-ALL) patients. A total of 46 subjects (anticipated) will be enrolled in this study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.
- •Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or
- •CD19 positivity confirmed by flow cytometry and/or histopathology.
排除标准
- •Primary immunodeficiency.
- •History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.
- •Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;
研究组 & 干预措施
GT719 Injection treatment group
GT719 Injection
干预措施: GT719 Injection (Biological)
结局指标
主要结局
Incidence and severity of adverse events per CTCAE 5.0
时间窗: From infusion to the end of the treatment at 12 months
To characterize the safety profile of GT719 in patients with recurrent/refractory CD19 positive adult B-cell malignant hematological tumor as measured by the incidence and severity of adverse events per CTCAE 5.0
次要结局
- Objective response rate(28 days post the first infusion, and follow-ups at Month 2, Month 3, Month 6, Month 9 and Month 12)