A Phase 1 interventional study of Rimiducid may be administered as indicated in Multiple Myeloma, sponsored by Poseida Therapeutics, Inc.. Active, not recruiting at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Poseida Therapeutics, Inc. (part of Hoffmann-La Roche) · Phase 1, Interventional, and Other
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).
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 100 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Poseida Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
First submitted before Poseida Therapeutics, Inc. became part of Hoffmann-La Roche.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who received previous treatment with P-BCMA-101. Rimiducid may be administered as indicated.
Drug: Rimiducid 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.
Also known as: Rimiducid (safety switch activator)
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
Time frame: Treatment with P-BCMA-101 through year 15
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
Time frame: Treatment with P-BCMA-101 through year 15
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Treatment with P-BCMA-101 through year 15
Biomarkers for P-BCMA-101 (Cell Count)
Absolute B and T lymphocyte count
Time frame: Treatment with P-BCMA-101 through year 15
Biomarkers for P-BCMA-101 (Expansion)
Expansion and/or persistence of P-BCMA-101 T cells
Time frame: 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
Time frame: 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.
Time frame: Rimiducid infusion through Year 15 after P-BCMA-101 infusion, if applicable
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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