P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma
MM
Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-BCMA-ALLO1 in Subjects With Relapsed / Refractory Multiple Myeloma (MM)
2 other identifiers
interventional
275
1 country
23
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 multiple-myeloma
Started May 2022
Longer than P75 for phase_1 multiple-myeloma
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2021
CompletedFirst Posted
Study publicly available on registry
July 14, 2021
CompletedStudy Start
First participant enrolled
May 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2042
April 24, 2026
April 1, 2026
6.8 years
June 24, 2021
April 22, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Phase 1 Part 1: Assess the safety and maximum tolerated dose (MTD) of P-BCMA-ALLO1 based on dose limiting toxicities (DLT)
Rate of dose limiting toxicities (DLT)
Baseline through Day 28
Phase 1 Part 2: Assess the safety and tolerability of P-BCMA-ALLO1 when administered as a fixed dose of cells.
Frequency and severity of adverse events, including cytokine release syndrome.
Baseline through 36 months
Phase 1b: The effect of cell dose and study arm
Overall response rate (ORR) based on International Myeloma Working Group (IMWG) uniform response criteria
Baseline through 36 months
Secondary Outcomes (3)
The safety of P-BCMA-ALLO1
Baseline through 15 years
The anti-myeloma effect of P-BCMA-ALLO1 (ORR) in Phase 1 Parts 1 and 2
Baseline through 15 years
Safety and Efficacy (anti-myeloma effect) will be used to guide the selection of RP2D
Baseline through 15 years
Study Arms (18)
P-BCMA-ALLO1 CAR-T cells (Arm S)
EXPERIMENTALSingle weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen S. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm F)
EXPERIMENTALSingle weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen F. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm N)
EXPERIMENTALSingle weight-based IV administration of P-BCMA-ALLO1. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm P1)
EXPERIMENTALSingle weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P1. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm P2)
EXPERIMENTALSingle weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P2. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm R)
EXPERIMENTALSingle weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen R. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm RS)
EXPERIMENTALSingle weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RS. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm C)
EXPERIMENTALCyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen C. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm160)
EXPERIMENTALSingle fixed dose IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen S, P1, P1.5 or P2. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm480)
EXPERIMENTALSingle fixed dose IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen S, P1, P1.5 or P2. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm P1.5)
EXPERIMENTALSingle weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P1.5. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm RP1)
EXPERIMENTALSingle weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP1. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm RP1.5)
EXPERIMENTALSingle weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP1.5. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm RP2)
EXPERIMENTALSingle weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP2. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm CP1)
EXPERIMENTALCyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP1. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm CP1.5)
EXPERIMENTALCyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP1.5. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm CP2)
EXPERIMENTALCyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP2. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells (Arm MP1.5)
EXPERIMENTALSingle weight based IV administration of P-BCMA-ALLO1 and methotrexate following conditioning chemotherapy regimen MP1.5 Rimiducid may be administered as indicated
Interventions
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Safety switch activator
Eligibility Criteria
You may qualify if:
- Must have signed written, informed consent.
- Males or females, ≥18 years of age.
- Must have a confirmed diagnosis of active MM.
- Must have measurable MM.
- Must have relapsed / refractory MM, having received treatment with a proteasome inhibitor, immunomodulatory agent (IMiD), and anti-CD38 therapy.
- 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.
- 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).
- Must be at least 90 days since autologous stem cell transplant, if performed.
- Must have adequate vital organ function within pre-determined parameters.
- Must have recovered from toxicities due to prior therapies.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
You may not qualify if:
- Is pregnant or lactating.
- Has inadequate venous access.
- Has active hemolytic anemia, plasma cell leukemia, Waldenstrom\'s macroglobulinemia, POEMS syndrome, disseminated intravascular coagulation, leukostasis, or amyloidosis.
- 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.
- Has active autoimmune disease.
- Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy, etc.
- Has an active systemic infection.
- 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.
- Is positive for cytomegalovirus (CMV) by PCR, CMV immunoglobulin M (IgM) antibody, or Coronavirus disease 2019 (COVID-19) by PCR.
- Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia.
- Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol.
- Has received prior allogeneic cellular therapy or gene therapy.
- Has received anti-cancer medications within 2 weeks of the time of initiating conditioning LD therapy.
- Has received monoclonal antibody therapy within 4 weeks of initiating conditioning LD therapy.
- 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Roche-Genentechcollaborator
- Poseida Therapeutics, Inc.lead
Study Sites (23)
City of Hope
Goodyear, Arizona, 85338, United States
University of California San Diego
San Diego, California, 92093, United States
University of California San Francisco
San Francisco, California, 94143, United States
Emory University
Atlanta, Georgia, 30322, United States
Blood Marrow and Transplant Group of Georgia
Atlanta, Georgia, 30342, United States
City of Hope
Chicago, Illinois, 60099, United States
Advocate Aurora Health
Park Ridge, Illinois, 66068, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201, United States
Wayne State - Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Hackensack Meridian Health
Hackensack, New Jersey, 07601, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
Mount Sinai
New York, New York, 10029, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-1350, United States
University of Cincinnati
Cincinnati, Ohio, 45221, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Oklahoma, Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4238, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Sarah Cannon Research Institute - St. David's South Austin Medical Center
Austin, Texas, 78704, United States
Houston Methodist Research Institute
Houston, Texas, 77030, United States
Sarah Cannon Research Institute - Methodist Healthcare
San Antonio, Texas, 78229, United States
Related Publications (1)
Tseng H, Dholaria B, Cranert SA, Richter M, Marquez KS, Cho BS, Bacong A, McArthur K, Eskew JD, McCaigue J, Haag S, Krasny A, Solimine B, Coffey MJ, Loyola A, Kwong J, Shune L, Kin A, Costello CL, Kocoglu MH, Ramakrishnan A, Namini H, Martin CE, Belani R, Coronella J, Shedlock DJ. TSCM-predominant allogeneic anti-BCMA CAR-T therapy for relapsed/refractory multiple myeloma: preclinical characterization and interim results from a phase 1 trial. Nat Commun. 2025 Nov 24;16(1):10050. doi: 10.1038/s41467-025-65267-0.
PMID: 41285709DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maika Onishi, M.D.
Senior Medical Director
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2021
First Posted
July 14, 2021
Study Start
May 5, 2022
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
March 1, 2042
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share