What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, including CAR-T cell therapies like P-BCMA-ALLO1, often have significant side effects. CAR-T cell therapies can cause cytokine release syndrome (CRS), neurotoxicity, infections, and cytopenias. Proteasome inhibitors (e.g., bortezomib) can lead to peripheral neuropathy, gastrointestinal issues, and hematologic toxicities. Immunomodulatory drugs (e.g., lenalidomide) may cause blood clots, fatigue, and cytopenias. Autologous stem cell transplants are associated with risks of infection, bleeding, and organ toxicity. Each treatment requires careful monitoring and management of these potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, including CAR-T cell therapies targeting BCMA. Notably, idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti) are CAR-T cell therapies that target BCMA and have shown efficacy in relapsed or refractory Multiple Myeloma. Additionally, other drugs such as bortezomib, lenalidomide, and daratumumab have been widely used in various combinations for treating Multiple Myeloma. These treatments have significantly improved outcomes for patients with this condition.

What other types of research exist?

Promising alternatives to P-BCMA-ALLO1 for Multiple Myeloma patients include other CAR-T cell therapies such as CD19-targeted CAR-T cells and autologous T cells genetically engineered to recognize CD19. Additionally, nonmyeloablative allogeneic stem cell transplants and novel immunotherapies like CD22-targeted therapies are also potential options.

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CAR T-cell Therapy

CAR-T Cell Therapy for Multiple Myeloma (MM Trial)

Phase 1

Recruiting

Research Sponsored by Poseida Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Must be at least 90 days since autologous stem cell transplant, if performed

Must not have

Has CNS metastases or symptomatic CNS involvement of their myeloma

Has an active systemic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new therapy using modified donor immune cells to treat patients with a difficult-to-treat type of blood cancer. The therapy aims to use these engineered cells to find and destroy the cancer cells. CAR-T cell therapy has become a new and highly effective treatment option, especially for patients with challenging blood cell cancers.

Who is the study for?

Adults with active Multiple Myeloma who've had prior treatments including proteasome inhibitors, IMiDs, and anti-CD38 therapy. They must have measurable disease that's relapsed/refractory, be willing to use birth control, and have good organ function. Excluded are pregnant individuals, those with certain viral infections or a history of severe allergies to trial drugs.

What is being tested?

The study is testing P-BCMA-ALLO1 CAR-T cells alongside Rimiducid in adults with Multiple Myeloma that has not responded to standard treatments. It's an early-phase trial where researchers will test different doses to find the safest and most effective one.

What are the potential side effects?

Potential side effects may include immune system reactions, infusion-related symptoms like fever or chills, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. Specific side effects related to CAR-T therapies can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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It has been over 90 days since my stem cell transplant.

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My vital organs are functioning well.

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I have been diagnosed with active multiple myeloma.

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My multiple myeloma has returned or didn't respond after treatment with specific drugs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain or spinal cord.

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I am currently fighting an infection in my body.

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I have a history of serious brain or nerve conditions like stroke or epilepsy.

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I have taken or might need immunosuppressive drugs recently or while in the study.

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I have severe heart issues, including heart failure or a recent heart attack.

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I have not taken systemic steroids recently and don't expect to need them during the study.

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I have had a stem cell transplant or any other organ transplant from a donor, or my own cells within the last 3 months.

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I have had a treatment involving cells or genes from a donor.

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I have a specific blood disorder such as hemolytic anemia or Waldenstrom's macroglobulinemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1 Part 1: Assess the safety and maximum tolerated dose (MTD) of P-BCMA-ALLO1 based on dose limiting toxicities (DLT)

Phase 1 Part 2: Assess the safety and tolerability of P-BCMA-ALLO1 when administered as a fixed dose of cells.

Phase 1b: The effect of cell dose and study arm to guide selection of Recommended Phase 2 Dose (RP2D).

Secondary study objectives

The anti-Myeloma effect of P-BCMA-ALLO1 (DOR)

The anti-Myeloma effect of P-BCMA-ALLO1 (OS)

The anti-Myeloma effect of P-BCMA-ALLO1 (PFS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

17Treatment groups

Experimental Treatment

Group I: P-BCMA-ALLO1 CAR-T cells (Arm480)Experimental Treatment2 Interventions

Single fixed dose IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen S, P1, P1.5 or P2. Rimiducid may be administered as indicated.

Group II: P-BCMA-ALLO1 CAR-T cells (Arm160)Experimental Treatment2 Interventions

Single fixed dose IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen S, P1, P1.5 or P2. Rimiducid may be administered as indicated.

Group III: P-BCMA-ALLO1 CAR-T cells (Arm S)Experimental Treatment2 Interventions

Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen S. Rimiducid may be administered as indicated.

Group IV: P-BCMA-ALLO1 CAR-T cells (Arm RS)Experimental Treatment2 Interventions

Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RS. Rimiducid may be administered as indicated.

Group V: P-BCMA-ALLO1 CAR-T cells (Arm RP2)Experimental Treatment2 Interventions

Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP2. Rimiducid may be administered as indicated.

Group VI: P-BCMA-ALLO1 CAR-T cells (Arm RP1.5)Experimental Treatment2 Interventions

Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP1.5. Rimiducid may be administered as indicated.

Group VII: P-BCMA-ALLO1 CAR-T cells (Arm RP1)Experimental Treatment2 Interventions

Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP1. Rimiducid may be administered as indicated.

Group VIII: P-BCMA-ALLO1 CAR-T cells (Arm R)Experimental Treatment2 Interventions

Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen R. Rimiducid may be administered as indicated.

Group IX: P-BCMA-ALLO1 CAR-T cells (Arm P2)Experimental Treatment2 Interventions

Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P2. Rimiducid may be administered as indicated.

Group X: P-BCMA-ALLO1 CAR-T cells (Arm P1.5)Experimental Treatment2 Interventions

Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P1.5. Rimiducid may be administered as indicated.

Group XI: P-BCMA-ALLO1 CAR-T cells (Arm P1)Experimental Treatment2 Interventions

Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P1. Rimiducid may be administered as indicated.

Group XII: P-BCMA-ALLO1 CAR-T cells (Arm N)Experimental Treatment2 Interventions

Single weight-based IV administration of P-BCMA-ALLO1. Rimiducid may be administered as indicated.

Group XIII: P-BCMA-ALLO1 CAR-T cells (Arm F)Experimental Treatment2 Interventions

Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen F. Rimiducid may be administered as indicated.

Group XIV: P-BCMA-ALLO1 CAR-T cells (Arm CP2)Experimental Treatment2 Interventions

Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP2. Rimiducid may be administered as indicated.

Group XV: P-BCMA-ALLO1 CAR-T cells (Arm CP1.5)Experimental Treatment2 Interventions

Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP1.5. Rimiducid may be administered as indicated.

Group XVI: P-BCMA-ALLO1 CAR-T cells (Arm CP1)Experimental Treatment2 Interventions

Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP1. Rimiducid may be administered as indicated.

Group XVII: P-BCMA-ALLO1 CAR-T cells (Arm C)Experimental Treatment2 Interventions

Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen C. Rimiducid may be administered as indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rimiducid

2019

Completed Phase 1

~20

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Myeloma treatments target the disease through various mechanisms. Proteasome inhibitors (e.g., bortezomib) disrupt protein degradation, leading to cancer cell death. Immunomodulatory drugs (e.g., lenalidomide) enhance immune response and inhibit tumor growth. Monoclonal antibodies (e.g., daratumumab) target specific antigens on myeloma cells, marking them for destruction by the immune system. CAR-T cell therapies, like those studied in the P-BCMA-ALLO1 trial, involve engineering T cells to target BCMA on myeloma cells, leading to direct cell killing. These treatments are crucial as they offer targeted, effective options for managing Multiple Myeloma, potentially leading to better outcomes and prolonged remission.