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Allogeneic CAR-T cell therapy for multiple myeloma

Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-BCMA-ALLO1 in Subjects With Relapsed / Refractory Multiple Myeloma (MM)

Phase 1 Interventional Poseida Therapeutics, Inc. · NCT04960579

This study is testing a new type of CAR-T cell therapy to see if it can safely help people with relapsed or hard-to-treat multiple myeloma.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment231 (estimated)
Ages18 Years and up
SexAll
SponsorPoseida Therapeutics, Inc. Industry-sponsored
Drugs / interventionsradiation, CAR-T
Locations21 sites (Goodyear, Arizona and 20 other locations)
Trial IDNCT04960579 on ClinicalTrials.gov

What this trial studies

This Phase 1 study evaluates the safety and efficacy of P-BCMA-ALLO1 allogeneic CAR-T cells in patients with relapsed or refractory multiple myeloma. It involves a dose escalation approach with multiple cohorts, where participants may receive lymphodepletion therapy prior to CAR-T cell administration. The study will monitor participants for safety, tolerability, and response to treatment through serial measurements. The trial aims to expand cohorts based on initial findings to further assess the treatment's potential.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with relapsed or refractory multiple myeloma who have previously received specific treatments.

Not a fit: Patients who have not previously been treated with a proteasome inhibitor, immunomodulatory agent, and anti-CD38 therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat multiple myeloma.

How similar studies have performed: Other studies using CAR-T cell therapies have shown promising results in treating multiple myeloma, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Must have signed written, informed consent.
2. Males or females, ≥18 years of age.
3. Must have a confirmed diagnosis of active MM.
4. Must have measurable MM.
5. Must have relapsed / refractory MM, having received treatment with a proteasome inhibitor, immunomodulatory agent (IMiD), and anti-CD38 therapy.
6. Must be willing to practice birth control from the time of Screening and throughout the first year of the study after P-BCMA-ALLO1 administration.
7. Must have a negative serum pregnancy test at Screening and a negative urine pregnancy test within 3 days prior to initiating the lymphodepletion therapy regimen (females of childbearing potential).
8. Must be at least 90 days since autologous stem cell transplant, if performed.
9. Must have adequate vital organ function within pre-determined parameters.
10. Must have recovered from toxicities due to prior therapies.
11. Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Exclusion Criteria:

1. Is pregnant or lactating.
2. Has inadequate venous access.
3. Has active hemolytic anemia, plasma cell leukemia, Waldenstrom\'s macroglobulinemia, POEMS syndrome, disseminated intravascular coagulation, leukostasis, or amyloidosis.
4. Has an active second malignancy (not disease-free for at least 5 years) in addition to MM, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma.
5. Has active autoimmune disease.
6. Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy, etc.
7. Has an active systemic infection.
8. Has a history of hepatitis B, hepatitis C virus, human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection, or any immunodeficiency syndrome. Subjects with a history of treated hepatitis C can be enrolled if negative by Hepatitis C PCR on multiple occasions and with medical monitor approval.
9. Is positive for cytomegalovirus (CMV) by PCR, CMV immunoglobulin M (IgM) antibody, or Coronavirus disease 2019 (COVID-19) by PCR.
10. Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia.
11. Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol.
12. Has received prior allogeneic cellular therapy or gene therapy.
13. Has received anti-cancer medications within 2 weeks of the time of initiating conditioning LD therapy.
14. Has received monoclonal antibody therapy within 4 weeks of initiating conditioning LD therapy.
15. Has received immunosuppressive medications within 2 weeks of the time of administration of P-BCMA-ALLO1, and/or expected to require them while on study.
16. Has received systemic corticosteroid therapy within 1 week or 5 half-lives (whichever is shorter) of the administration of P-BCMA-ALLO1 or is expected to require it during the course of the study.
17. Has CNS metastases or symptomatic CNS involvement of their myeloma.
18. Has a history of severe immediate hypersensitivity reaction to any of the agents used in this study.
19. Has a history of having undergone allogeneic stem cell transplantation, or any other allogeneic or xenogeneic transplant, or has undergone autologous transplantation within 90 days.
20. Arms R, RS, RP1, RP1.5 and RP2 Only: a) Has received a live vaccine within the last 28 days of the first administration of agents used in Arm R or RS, b) Has any known hypersensitivity or severe reactions or toxicity to agents used in Arms R or RS.
21. Has received radiation within 1 week of initiating conditioning LD therapy.

Where this trial is running

Goodyear, Arizona and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple Myeloma
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.