Long-Term Follow-Up Study for Subjects Treated With P-BCMA-101
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT03741127
- Lead Sponsor
- Poseida Therapeutics, Inc.
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Subjects who have received P-BCMA-101 and completed or discontinued early from a Poseida sponsored treatment protocol.
- Subject has provided informed consent.
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description P-BCMA-101 treated Rimiducid may be administered as indicated Patients who received previous treatment with P-BCMA-101. Rimiducid may be administered as indicated.
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 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
- Secondary Outcome Measures
Name Time Method Anti-myeloma effect of P-BCMA-101 (Response Rate) Treatment with P-BCMA-101 through year 15 Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma
Effect of rimiducid on grade of P-BCMA-101-related adverse events Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable Effect of rimiducid on grade of P-BCMA-101-related adverse events as assessed by CTCAE v4.03, if indicated.
Anti-myeloma effect of P-BCMA-101 (Time to Response) Treatment with P-BCMA-101 through year 15 Time from P-BCMA-101 administration to time of first documented response (PR or better) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma.
Anti-myeloma effect of P-BCMA-101 (Duration of Response) Treatment with P-BCMA-101 through year 15 Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma.
Anti-myeloma effect of P-BCMA-101 (Progression Free Survival) Treatment with P-BCMA-101 through year 15 Time from P-BCMA-101 treatment to progressive disease according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma, or death
Anti-myeloma effect of P-BCMA-101 (Overall Survival) Treatment with P-BCMA-101 through year 15 Duration of survival from time of treatment with P-BCMA-101
Concentration of P-BCMA-101 cells Treatment with P-BCMA-101 through year 15 Concentration of P-BCMA-101 cells in blood and bone marrow over time
Biomarkers for P-BCMA-101 (BCMA Cells) Treatment with P-BCMA-101 through year 15 The persistence of anti-tumor effect of P-BCMA-101 and its relationship to persistence of P-BCMA-101 cells, BCMA tumor surface expression and circulating BCMA.
Biomarkers for P-BCMA-101 (Cell Count) Treatment with P-BCMA-101 through year 15 Absolute B and T lymphocyte count
Biomarkers for P-BCMA-101 (Expansion) Treatment with P-BCMA-101 through year 15 Expansion and/or persistence of P-BCMA-101 T cells
Incidence of adverse events related to rimiducid, if indicated Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable Incidence of adverse events related to rimiducid, if indicated
Trial Locations
- Locations (13)
Sarah Cannon Research Institute at Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
University of California, San Diego
🇺🇸San Diego, California, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Maryland Greenebaum Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of California Davis
🇺🇸Davis, California, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
University of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
Wayne State - Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States