Multiple Myeloma
Conditions
Keywords
CAR-T cells
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).
Interventions
DRUGRimiducid may be administered as indicated
Patients who received P-BCMA-101 in a previous trial will be evaluated in this trial for long term safety and efficacy. Rimiducid (safety switch activator) may be administered as indicated.
Sponsors
Poseida Therapeutics, Inc.
California Institute for Regenerative Medicine (CIRM)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who have received P-BCMA-101 and completed or discontinued early from a Poseida sponsored treatment protocol. * Subject has provided informed consent.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
Countries
United States
Contacts
STUDY_DIRECTORMaika Onishi,, M.D., P.h.D
Sponsor Medical Director
Outcome results
None listed