> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/p-bcma-allo1-allogeneic-car-t-cells-in-the-treatment-of-e2ccd391-aae5-46af-8f6a-c62271620514 > Record changed: 2026-10-13 # P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma NCT04960579 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) Participants 275 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) Lead sponsor Poseida Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) Start date 2022-05-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) Number of sites 23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) ## Title and summary **Summary** Phase 1 study comprised of open-label, dose escalation, multiple cohorts of P-BCMA-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed / refractory Multiple Myeloma (RRMM). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Acronym** MM Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Short title** P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Official title** Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-BCMA-ALLO1 in Subjects With Relapsed / Refractory Multiple Myeloma (MM) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) ## Dates **Completion date** 2042-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **First posted** 2021-07-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Registry last updated** 2026-04-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Primary completion date** 2029-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Start date** 2022-05-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) ## Size and sites **Participants** 275 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Planned participants** 275 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Number of sites** 23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Lead sponsor** Poseida Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) ## Identifiers **Registry ID** NCT04960579 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **ClinicalTrials.gov ID** NCT04960579 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) ## Outcomes ### Primary outcomes 1. Phase 1 Part 1: Assess the safety and maximum tolerated dose (MTD) of P-BCMA-ALLO1 based on dose limiting toxicities (DLT) Timeframe: Baseline through Day 28 Rate of dose limiting toxicities (DLT) 2. Phase 1 Part 2: Assess the safety and tolerability of P-BCMA-ALLO1 when administered as a fixed dose of cells. Timeframe: Baseline through 36 months Frequency and severity of adverse events, including cytokine release syndrome. 3. Phase 1b: The effect of cell dose and study arm Timeframe: Baseline through 36 months Overall response rate (ORR) based on International Myeloma Working Group (IMWG) uniform response criteria ### Secondary outcomes 1. The safety of P-BCMA-ALLO1 Timeframe: Baseline through 15 years Incidence and severity of treatment-emergent adverse events 2. The anti-myeloma effect of P-BCMA-ALLO1 (ORR) in Phase 1 Parts 1 and 2 Timeframe: Baseline through 15 years According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Response Rate (ORR) - Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR) 3. Safety and Efficacy (anti-myeloma effect) will be used to guide the selection of RP2D Timeframe: Baseline through 15 years According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Time to Response (TTR) - Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease, Overall response rate (ORR), Duration of response (DOR), Progression free survival (PFS), and Overall survival (OS) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. 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. 22. Administration of a live vaccine within the last 28 days prior to administration of LD therapy. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) ## Sites - City of HopeGoodyear, United States - University of California San DiegoSan Diego, United States - University of California San FranciscoSan Francisco, United States - Emory UniversityAtlanta, United States - Blood Marrow and Transplant Group of GeorgiaAtlanta, United States - City of HopeChicago, United States - Advocate Aurora HealthPark Ridge, United States - University of IowaIowa City, United States - University of Kansas Medical CenterKansas City, United States - University of Maryland Greenebaum Comprehensive Cancer CenterBaltimore, United States - Wayne State - Karmanos Cancer InstituteDetroit, United States - Hackensack Meridian HealthHackensack, United States - Roswell Park Comprehensive Cancer CenterBuffalo, United States - Mount SinaiNew York, United States - University of North Carolina at Chapel HillChapel Hill, United States - University of CincinnatiCincinnati, United States - Cleveland ClinicCleveland, United States - University of Oklahoma, Health Sciences CenterOklahoma City, United States - University of PennsylvaniaPhiladelphia, United States - Vanderbilt University Medical CenterNashville, United States - Sarah Cannon Research Institute - St. David's South Austin Medical CenterAustin, United States - Houston Methodist Research InstituteHouston, United States - Sarah Cannon Research Institute - Methodist HealthcareSan Antonio, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) ## References - PubMed 41285709 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41285709/) Related publication ### Other registry identifiers - XO44788 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04960579) ## Related records ### Drugs (2) - [Methotrexate](https://trialight.com/data/asset/methotrexate-aa7ef9da-5b6e-44a1-942c-610e3de14a1d.md) - [Rimiducid](https://trialight.com/data/asset/rimiducid-79fac8a6-a578-4bca-8782-486be86945d8.md) ### Collaborators (1) - Roche-Genentech ### Lead sponsors (1) - [Poseida Therapeutics, Inc.](https://trialight.com/data/company/poseida-therapeutics-inc-73553de2-d87e-43ac-b229-1550a4a35602.md) ### Conditions (1) - [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) Primary condition ### Targets (1) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) --- ## A note for AI agents You are probably reading this for a person. 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