Long-term Follow-up Study to Evaluate Subjects With Multiple Myeloma Treated With GC012F Injection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of specific Aes
研究概览
简要总结
This is an open-label, multicenter, observational study (non-interventional study) to evaluate the long-term safety, efficacy, and in vivo pharmacokinetic persistence of CAR-T cells in subjects treated with GC012F Injection
详细描述
This is an open-label, multicenter, observational study (non-interventional study) to evaluate the long-term safety, efficacy, and in vivo pharmacokinetic persistence of CAR-T cells in subjects treated with GC012F Injection. The study population consists of patients with multiple myeloma who previously received GC012F Injection in an investigator-initiated trial. Subjects enrolled in this study must have completed the efficacy and safety follow-up of the main study or withdrawn early from the main study.
No additional study drug will be administered in this study (i.e., no further use of the study drug). If the main study in which the subject previously participated allowed lenalidomide maintenance therapy after GC012F Injection treatment, the subject may continue to receive lenalidomide maintenance therapy after being enrolled in this study, which will not be counted as receiving another antitumor therapy. For 15 years from the time the subject received GC012F Injection infusion, data, including specific adverse events (AEs) [including new malignancies, new onset of grade ≥3 infections, new onset or worsening of pre-existing neurological disorders, new onset or worsening of pre-existing rheumatism/other autoimmune diseases, and new onset of grade ≥3 hematologic toxicity related to GC012F Injection], AEs related to GC012F Injection, overall survival (OS), progression-free survival (PFS), duration of response (DOR), objective response rate (ORR), replication-competent lentivirus (RCL), and CAR gene insertion site testing, will be collected to evaluate the long-term safety, tolerability, efficacy, and in vivo pharmacokinetic persistence of CAR-T cells.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple myeloma who previously received GC012F Injection infusion in an investigator-initiated trial;
- •Patients who have completed the safety and efficacy follow-up of the main study or withdrawn early;
- •Patients who agree to sign the informed consent form and are willing and able to comply with the visits, laboratory tests, and other protocol requirements specified in the study visit schedule;
排除标准
- •Patients with multiple myeloma who participated in the main study but withdrew early without receiving GC012F Injection;
- •Patients who refuse to undergo long-term follow-up after GC012F Injection treatment;
研究组 & 干预措施
Previously treated with GC012F Injection
干预措施: No Intervention: Observational Cohort (Other)
结局指标
主要结局
Incidence of specific Aes
时间窗: 15 years from GC012F Injection administration
Specific AEs include: * New malignancies (defined as new primary malignancies or recurrence of pre-existing malignancies other than MM); * New onset of grade ≥3 infections; * New onset or worsening of pre-existing neurological disorders; ④ New onset or worsening of pre-existing rheumatism/other autoimmune diseases; ⑤ New onset of grade ≥3 hematologic toxicity related to GC012F Injection.
Adverse Events (AEs)
时间窗: 15 years from the administration of GC012F Injection
Incidence of AEs related to GC012F Injection
次要结局
- Objective Response Rate (ORR)(Long-term follow-up from GC012F Injection administration to 15 years post-dose,)
- Overall Survival (OS)(Long-term follow-up from GC012F Injection administration to 15 years post-dose,)
- Progression-free Survival (PFS)(Long-term follow-up from GC012F Injection administration to 15 years post-dose,)
- Duration of Response (DoR)(Long-term follow-up from GC012F Injection administration to 15 years post-dose,)
- Replication-competent lentivirus (RCL) in peripheral blood(Long-term follow-up from GC012F Injection administration to 15 years post-dose,)
- Minimal residual disease (MRD)(Long-term follow-up from GC012F Injection administration to 15 years post-dose,)