Open Label, Multicenter, Long-Term Follow-Up Study for Subjects Treated With P-BCMA-101
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 13
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
Subjects are enrolled in this study following completion or early discontinuation from a Poseida sponsored or supported study of P-BCMA-101 T cells and will be followed for a total of 15 years post treatment from the last P-BCMA-101 treatment. Subjects will be monitored for safety and efficacy to assess the risk of delayed adverse events (AEs) and assess long-term efficacy, and PK and quantification of P-BCMA-101 T cells. Rimiducid may be administered as indicated.
详细描述
Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (FDA, 2006; Guidance for Industry, Gene Therapy Clinical Trials-Observing Subjects for Delayed Adverse Events), long term safety and efficacy follow up of treated subjects is required. Subjects are enrolled in this study following completion or early discontinuation from a Poseida sponsored or supported study of P-BCMA-101 T cells and will be followed for a total of 15 years post treatment from the last P-BCMA-101 treatment. Subjects will be monitored for safety and efficacy to assess the risk of delayed adverse events (AEs) and assess long-term efficacy, and PK and quantification of P-BCMA-101 T cells. Rimiducid may be administered as indicated.
Study visits Subjects will only enter this protocol after completing or discontinuing from their primary P-BCMA-101 protocol.
Once enrolled in this protocol a subject will return for regular follow-up depending on when they last received P-BCMA-101 on their primary protocol:
- Every 3 months until the end of the first year after P-BCMA-101 treatment
- Every 6 months until the end of the third year after P-BCMA-101 treatment
- Then yearly until the end of the 15th year after P-BCMA-101 treatment (ie. if a subject discontinues from their primary protocol 2 years after receiving P-BCMA-101, they will be entering this study at the beginning of the 3rd year, and will remain on this study for 13 years).
Subjects will undergo serial assessment of safety, chemistry, hematology, and disease response as specified in the Schedule of Events. Subjects will further undergo a physical exam and medical history, and anti-myeloma medications, related AEs, new malignancies, new or exacerbated clinically significant neurologic, hematologic, rheumatologic or other autoimmune disorders will be recorded. After progressive disease (PD) has been confirmed for a subject after P-BCMA-101 administration, visits may be performed remotely (AEs collected by telephone and laboratory studies completed at a local facility).
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
- •Subjects who have received P-BCMA-101 and completed or discontinued early from a Poseida sponsored treatment protocol.
- •Subject has provided informed consent.
排除标准
- 未提供
研究组 & 干预措施
P-BCMA-101 treated
Patients who received previous treatment with P-BCMA-101. Rimiducid may be administered as indicated.
干预措施: Rimiducid may be administered as indicated (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Treatment with P-BCMA-101 through year 15
Incidence and severity of treatment-emergent adverse events to evaluate the long-term safety of P-BCMA-101
次要结局
- Anti-myeloma effect of P-BCMA-101 (Response Rate)(Treatment with P-BCMA-101 through year 15)
- Anti-myeloma effect of P-BCMA-101 (Time to Response)(Treatment with P-BCMA-101 through year 15)
- Anti-myeloma effect of P-BCMA-101 (Duration of Response)(Treatment with P-BCMA-101 through year 15)
- Anti-myeloma effect of P-BCMA-101 (Progression Free Survival)(Treatment with P-BCMA-101 through year 15)
- Anti-myeloma effect of P-BCMA-101 (Overall Survival)(Treatment with P-BCMA-101 through year 15)
- Concentration of P-BCMA-101 cells(Treatment with P-BCMA-101 through year 15)
- Biomarkers for P-BCMA-101 (BCMA Cells)(Treatment with P-BCMA-101 through year 15)
- Biomarkers for P-BCMA-101 (Cell Count)(Treatment with P-BCMA-101 through year 15)
- Biomarkers for P-BCMA-101 (Expansion)(Treatment with P-BCMA-101 through year 15)
- Incidence of adverse events related to rimiducid, if indicated(Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable)
- Effect of rimiducid on grade of P-BCMA-101-related adverse events(Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable)