A Long-term Follow-up Study of GF-01-01 to Evaluate the Safety and Persistence of GF-CART01 (CD20/19 CAR T Cell) in Subjects With Relapsed or Refractory B-Cell Hematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Long-Term Safety of GF-CART01 after infusion
研究概览
简要总结
The goal of this observational study is to learn about the long-term safety of GF-CART01 after cell infusion up to 15 years.
详细描述
This comprehensive long-term follow-up study is meticulously designed to assess the safety and persistence of GF-CART01. Subjects who participated in the initial study of GF-01-01 and received treatment with GF-CART01, irrespective of their completion status, are eligible to participate in this follow-up study. The study may allow for a maximum enrollment of 18 subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects previously enrolled in the study of GF-CART01 (Protocol No.: GF-01-01) and received GF-CART01 infusion
- •Subjects or their legal guardians must volunteer to participate in the study and sign the informed consent
- •Willingness and ability to comply with protocol-stated requirements, instructions, and restrictions in the investigator's judgement
排除标准
- 未提供
研究组 & 干预措施
LTFU
Subjects who participated in the initial study of GF-01-01 and received treatment with GF-CART01, irrespective of their completion status, are invited to participate in this follow-up study.
结局指标
主要结局
Long-Term Safety of GF-CART01 after infusion
时间窗: up to 15 years after GF-CART01 infusion
Percentage of subjects with ≥ grade 3 GF-CART01-related adverse events, serious adverse events (SAEs), adverse events of special interest (AESIs)
次要结局
- GF-CART01 persistence(up to 15 years after GF-CART01 infusion)
- Efficacy of GF-CART01(up to 15 years after GF-CART01 infusion)