A Study to Evaluate the Long-Term Safety of CLBR001, A Lentiviral Based Chimeric Antigen Receptor, In Patients With B-Cell Malignancies Previously Administered CLBR001
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 36
- 试验地点
- 15
- 主要终点
- Incidence and duration of new adverse events, late onset adverse events, and events of special interest
研究概览
简要总结
This study is designed as a long-term follow-up study of participants who have receive genetically modified autologous CLBR001 CAR-T cells
详细描述
Patients will be enrolled following either the completion or early termination/discontinuation from Study NCT04450069 or any protocol in which patients were administered CLBR001. Patients will begin the long-term follow-up period regardless of whether they responded to treatment or progressed on treatment. Patients will be followed for up to 15 years post CLBR001 infusion and will continue to be monitored for safety, immunogenicity, and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •All patients who received at least one CLBR001 cell dose and have either discontinued early or completed the core treatment protocol or any protocol such as a managed access protocol as applicable.
- •Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
排除标准
- •There are no specific exclusion criteria for this study
研究组 & 干预措施
CLBR001 treated patients
Patients who have been administered with CLBR001
干预措施: CLBR001 and SWI019 (Combination Product)
结局指标
主要结局
Incidence and duration of new adverse events, late onset adverse events, and events of special interest
时间窗: 15 years
To measure the incidence and duration of new adverse events, late onset adverse events, and events of special interest
Incidence and duration of new serious adverse events
时间窗: 15 years
To measure the incidence and duration of new serious adverse events
Incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001
时间窗: 15 years
The measure the incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001
Incidence of new malignancies
时间窗: 15 years
The measure the incidence of new malignancies
次要结局
- Proportion of patients undergoing stem cell transplant(15 years)
- Number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens(3, 6, 9,12 and 24 months)
- Titer of anti-drug antibody (ADA) for CLBR001 and SWI019(3, 6, 12 months)
- Duration of response(15 years)
- Progression free survival(15 years)
- Overall response(15 years)
- Duration of detection of ADA for CLBR001 and SWI019(3, 6, 12 months)
- Detectable replication competent lentivirus (RCL)(15 years)