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

Not currently recruiting at 15 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Poseida Therapeutics, Inc.

Must be taking: P-BCMA-101

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Varies based on primary protocol

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of a treatment called P-BCMA-101 for people with multiple myeloma, a type of blood cancer. Researchers will monitor participants for 15 years to identify any long-term side effects or benefits. Individuals previously treated with P-BCMA-101 in a Poseida study, who have completed or exited that study early, are suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially groundbreaking therapy.

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.

Is there any evidence suggesting that P-BCMA-101 is likely to be safe for humans?

Research shows that P-BCMA-101, a type of CAR-T cell therapy, has potential in treating multiple myeloma, a kind of blood cancer. Earlier studies found that many patients tolerated this treatment well. Some experienced side effects, but these were usually manageable.

Researchers have studied the safety of P-BCMA-101 in patients with difficult cases of multiple myeloma. While some unwanted side effects occurred, the treatment's overall safety was considered acceptable given its potential benefits. These side effects are similar to those seen in other CAR-T therapies, which are already approved for other conditions.

Rimiducid is sometimes used to manage side effects of CAR-T therapies. Research suggests it can help when patients have reactions that don't respond to other treatments.

Participants in the trial will be closely monitored for any delayed side effects to ensure their long-term safety. This monitoring enhances understanding of the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

P-BCMA-101 is unique because it targets a specific protein called BCMA found on multiple myeloma cells. Unlike traditional treatments like chemotherapy and immunomodulatory drugs that target cancer cells more broadly, P-BCMA-101 uses a CAR-T cell therapy approach, which involves engineering a patient’s own immune cells to better recognize and attack myeloma cells. Researchers are excited about this treatment because it has the potential to offer a more targeted and personalized approach, which could lead to better responses and fewer side effects compared to existing therapies.

What evidence suggests that P-BCMA-101 might be an effective treatment for multiple myeloma?

Research has shown that P-BCMA-101, a type of CAR-T cell therapy, holds promise for treating multiple myeloma, particularly in patients whose cancer has returned or resisted other treatments. Studies have found that patients treated with P-BCMA-101 experienced a significant response, with many seeing a decrease in cancer cells. Specifically, one study involving 43 patients who had already tried many treatments showed positive results with P-BCMA-101. This treatment reprograms the body's immune cells to better locate and attack cancer cells. While the results are encouraging, ongoing monitoring in this trial will help determine its long-term effectiveness and safety. ^{1 2 4 6 7}

Who Is on the Research Team?

Semira Sheikh,, M.D., P.h.D

Principal Investigator

Sponsor Medical Director

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• P-BCMA-101
• Rimiducid

Trial Overview The 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.

How Is the Trial Designed?

Group I: P-BCMA-101 treated Experimental Treatment 1 Intervention

Patients who received previous treatment with P-BCMA-101. Rimiducid may be administered as indicated.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Options at the time of relapse after anti-BCMA therapy. Razzo, B., Garfall, AL., Cohen, AD.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03741127

Long-Term Follow-Up Study for Subjects Treated With P ... 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 ...

2. poseida.com poseida.com/wp-content/uploads/2021/01/Efficacy-and-safety-of-P-BCMA-101-CAR-T-cells-inpatients-with-relapsed-refractory-multiple-myeloma-MM.pdf

Efficacy and safety of P-BCMA-101 CAR-T cells in patients ... Efficacy and safety of P-BCMA-101 CAR-T cells in patients with relapsed/refractory (r/r) multiple myeloma (MM)​. C. Costello6, A. D. Cohen5, K. K. Patel3, S ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03288493

NCT03288493 | P-BCMA-101 Tscm CAR-T Cells in the ... Phase 2: Assess the Efficacy of P-BCMA-101 (ORR). According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0006497118693553

Phase 1/2 Study of the Safety and Response of P-BCMA ... As of 30Jun20, 43 patients had been treated with P-BCMA-101 (M/F 67%/33%, median age 60 years). Patients were heavily pre-treated (median of 7 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10082354/

Interventions and outcomes of patients with multiple ... In a cohort of 79 patients relapsing after BCMA-directed CAR T, multiple lines of salvage therapy led to a median overall survival of 17.9 months.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7713173/

Safety and clinical efficacy of BCMA CAR-T-cell therapy in ... Although considerable toxicity was observed, BCMA-targeted CAR-T-cell therapy is highly efficacious even in advanced multiple myeloma. Subgroup ...

7. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/3479/503645/Early-Safety-Results-of-P-BCMA-ALLO1-a-Fully

Early Safety Results of P-BCMA-ALLO1, a Fully Allogeneic ... The primary objective is to assess the safety and maximum tolerated dose (MTD) of P-BCMA-ALLO1 based on dose limiting toxicity (DLT) in RRMM ...