100 Participants Needed

Long-Term Follow-Up of P-BCMA-101 for Multiple Myeloma

Recruiting at 15 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Poseida Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications, so it's unclear. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment P-BCMA-101 for Multiple Myeloma?

Research shows that BCMA-targeting therapies, like P-BCMA-101, have been effective in treating multiple myeloma, especially in patients who have already tried other treatments. These therapies have shown high response rates in clinical trials, offering hope for patients with limited options.12345

Is P-BCMA-101 safe for humans?

Research on BCMA-targeted therapies, including CAR T-cell treatments like P-BCMA-101, shows they generally have a manageable safety profile in multiple myeloma patients, with common mild side effects such as cytokine release syndrome (a reaction that can cause fever and fatigue).36789

How is the treatment P-BCMA-101 different from other treatments for multiple myeloma?

P-BCMA-101 is a novel treatment that targets B-cell maturation antigen (BCMA), which is highly expressed in multiple myeloma cells. This approach is part of a new wave of immunotherapies that aim to improve patient outcomes by specifically targeting cancer cells and modifying the immune environment, offering a unique mechanism compared to traditional therapies.13101112

Research Team

RB

Rajesh Belani, M.D.

Principal Investigator

Sponsor Executive Medical Director

Eligibility Criteria

This trial is for individuals who have previously received P-BCMA-101 T cell treatment for multiple myeloma, either completing or discontinuing early from a Poseida sponsored study. Participants must consent to long-term follow-up.

Inclusion Criteria

You have already taken P-BCMA-101 as part of another study sponsored by Poseida and either finished or stopped early.
Subject has provided informed consent.

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive P-BCMA-101 T cells treatment

Varies based on primary protocol

Follow-up

Participants are monitored for safety and efficacy to assess the risk of delayed adverse events and long-term efficacy

15 years
Every 3 months for 1 year, every 6 months for 2 years, then yearly until year 15

Open-label extension

Participants may receive Rimiducid as indicated and are monitored for long-term safety and efficacy

15 years

Treatment Details

Interventions

  • P-BCMA-101
  • Rimiducid
Trial OverviewThe study monitors the safety and effectiveness of P-BCMA-101 T cells over 15 years post-treatment. It evaluates the risk of delayed side effects, ongoing benefits, and tracks levels of these specialized T cells in subjects.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: P-BCMA-101 treatedExperimental Treatment1 Intervention
Patients who received previous treatment with P-BCMA-101. Rimiducid may be administered as indicated.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Poseida Therapeutics, Inc.

Lead Sponsor

Trials
6
Recruited
780+

California Institute for Regenerative Medicine (CIRM)

Collaborator

Trials
70
Recruited
3,300+

Findings from Research

BCMA-directed therapies, such as antibody-drug conjugates and CAR T cells, have shown significant effectiveness in treating late-stage myeloma patients who have previously undergone various treatments, but the best order for using these therapies is still unclear.
After anti-BCMA therapy, there are several promising treatment options available, including alternative BCMA therapies and non-BCMA therapies, but more research is needed to personalize treatment strategies based on individual patient factors and disease characteristics.
Options at the time of relapse after anti-BCMA therapy.Razzo, B., Garfall, AL., Cohen, AD.[2023]
HBI0101, a novel anti-BCMA CAR T-cell therapy, demonstrated a high overall response rate of 75% in a phase I study involving 20 heavily pre-treated patients with relapsed/refractory multiple myeloma, with a dose-dependent increase in efficacy observed in higher doses.
The therapy showed a manageable safety profile, with 90% of patients experiencing only mild cytokine release syndrome and no severe toxicities, indicating that HBI0101 could be a safe and effective treatment option for this patient population.
Development and manufacture of novel locally produced anti-BCMA CAR T cells for the treatment of relapsed/refractory multiple myeloma: results from a phase I clinical trial.Asherie, N., Kfir-Erenfeld, S., Avni, B., et al.[2023]
In a study of 203 patients with multiple myeloma, those previously treated with BCMA-targeted therapies had lower response rates and shorter durations of response when treated with idecabtagene vicleucel (ide-cel) compared to those without prior BCMA treatment.
Despite the lower efficacy in patients with prior BCMA therapy, ide-cel still produced meaningful clinical responses, particularly in patients who had received anti-BCMA CAR T therapy, indicating that sequential BCMA-targeted treatments can still be beneficial.
Real-world experience of patients with multiple myeloma receiving ide-cel after a prior BCMA-targeted therapy.Ferreri, CJ., Hildebrandt, MAT., Hashmi, H., et al.[2023]

References

Options at the time of relapse after anti-BCMA therapy. [2023]
Selinexor-based regimens in patients with multiple myeloma after prior anti-B-cell maturation antigen treatment. [2023]
BCMA-Targeting Therapy: Driving a New Era of Immunotherapy in Multiple Myeloma. [2023]
Targeting B-cell maturation antigen in multiple myeloma. [2022]
Ten years of improvement in the management of multiple myeloma: 2000-2010. [2018]
Development and manufacture of novel locally produced anti-BCMA CAR T cells for the treatment of relapsed/refractory multiple myeloma: results from a phase I clinical trial. [2023]
Anti-BCMA novel therapies for multiple myeloma. [2023]
Targeting B Cell Maturation Antigen in Patients with Multiple Myeloma: Current Perspectives. [2023]
The Agony of Choice-Where to Place the Wave of BCMA-Targeted Therapies in the Multiple Myeloma Treatment Puzzle in 2022 and Beyond. [2021]
B-cell maturation antigen (BCMA) in multiple myeloma: rationale for targeting and current therapeutic approaches. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Real-world experience of patients with multiple myeloma receiving ide-cel after a prior BCMA-targeted therapy. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Myeloma: next generation immunotherapy. [2020]