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| Name | Class |
|---|---|
| California Institute for Regenerative Medicine (CIRM) | OTHER |
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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.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P-BCMA-101 treated | Other | Patients who received previous treatment with P-BCMA-101. Rimiducid may be administered as indicated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimiducid may be administered as indicated | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence and severity of treatment-emergent adverse events to evaluate the long-term safety of P-BCMA-101 | Treatment with P-BCMA-101 through year 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-myeloma effect of P-BCMA-101 (Response Rate) | 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 | Treatment with P-BCMA-101 through year 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maika Onishi,, M.D., P.h.D | Sponsor Medical Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis | Davis | California | 95618 | United States | ||
| University of California, San Diego |
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| Anti-myeloma effect of P-BCMA-101 (Time to Response) |
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. |
| Treatment with P-BCMA-101 through year 15 |
| Anti-myeloma effect of P-BCMA-101 (Duration of Response) | 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. | Treatment with P-BCMA-101 through year 15 |
| Anti-myeloma effect of P-BCMA-101 (Progression Free Survival) | 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 | Treatment with P-BCMA-101 through year 15 |
| Anti-myeloma effect of P-BCMA-101 (Overall Survival) | Duration of survival from time of treatment with P-BCMA-101 | Treatment with P-BCMA-101 through year 15 |
| Concentration of P-BCMA-101 cells | Concentration of P-BCMA-101 cells in blood and bone marrow over time | Treatment with P-BCMA-101 through year 15 |
| Biomarkers for P-BCMA-101 (BCMA Cells) | 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. | Treatment with P-BCMA-101 through year 15 |
| Biomarkers for P-BCMA-101 (Cell Count) | Absolute B and T lymphocyte count | Treatment with P-BCMA-101 through year 15 |
| Biomarkers for P-BCMA-101 (Expansion) | Expansion and/or persistence of P-BCMA-101 T cells | Treatment with P-BCMA-101 through year 15 |
| Incidence of adverse events related to rimiducid, if indicated | 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 | Effect of rimiducid on grade of P-BCMA-101-related adverse events as assessed by CTCAE v4.03, if indicated. | Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable |
| San Diego |
| California |
| 92121 |
| United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| University of Maryland Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Wayne State - Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Sarah Cannon Research Institute at Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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