P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma
NCT ID: NCT04960579
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
275 participants
INTERVENTIONAL
2022-05-05
2042-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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P-BCMA-ALLO1 CAR-T cells (Arm160)
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.
P-BCMA-ALLO1 CAR-T cells
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
P-BCMA-ALLO1 CAR-T cells (Arm480)
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.
P-BCMA-ALLO1 CAR-T cells
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
P-BCMA-ALLO1 CAR-T cells (Arm P1.5)
Single 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
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
P-BCMA-ALLO1 CAR-T cells (Arm RP1)
Single 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
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
P-BCMA-ALLO1 CAR-T cells (Arm RP1.5)
Single 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
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
P-BCMA-ALLO1 CAR-T cells (Arm RP2)
Single 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
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
P-BCMA-ALLO1 CAR-T cells (Arm CP1)
Cyclic 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
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
P-BCMA-ALLO1 CAR-T cells (Arm CP1.5)
Cyclic 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
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
P-BCMA-ALLO1 CAR-T cells (Arm CP2)
Cyclic 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
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
P-BCMA-ALLO1 CAR-T cells (Arm MP1.5)
Single weight based IV administration of P-BCMA-ALLO1 and methotrexate following conditioning chemotherapy regimen MP1.5 Rimiducid may be administered as indicated
P-BCMA-ALLO1 CAR-T cells
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
Methotrexate
Anti-metabolite
P-BCMA-ALLO1 CAR-T cells (Arm S)
Single 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
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
P-BCMA-ALLO1 CAR-T cells (Arm F)
Single 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
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
P-BCMA-ALLO1 CAR-T cells (Arm N)
Single weight-based IV administration of P-BCMA-ALLO1. Rimiducid may be administered as indicated.
P-BCMA-ALLO1 CAR-T cells
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
P-BCMA-ALLO1 CAR-T cells (Arm P1)
Single 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
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
P-BCMA-ALLO1 CAR-T cells (Arm P2)
Single 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
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
P-BCMA-ALLO1 CAR-T cells (Arm R)
Single 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
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
P-BCMA-ALLO1 CAR-T cells (Arm RS)
Single 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
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
P-BCMA-ALLO1 CAR-T cells (Arm C)
Cyclic 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
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
Interventions
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P-BCMA-ALLO1 CAR-T cells
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
Rimiducid
Safety switch activator
Methotrexate
Anti-metabolite
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Roche-Genentech
INDUSTRY
Poseida Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Maika Onishi, M.D.
Role: STUDY_DIRECTOR
Senior Medical Director
Locations
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City of Hope
Goodyear, Arizona, United States
University of California San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
Blood Marrow and Transplant Group of Georgia
Atlanta, Georgia, United States
City of Hope
Chicago, Illinois, United States
Advocate Aurora Health
Park Ridge, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Wayne State - Karmanos Cancer Institute
Detroit, Michigan, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Oklahoma, Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Sarah Cannon Research Institute - St. David's South Austin Medical Center
Austin, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
Sarah Cannon Research Institute - Methodist Healthcare
San Antonio, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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XO44788
Identifier Type: OTHER
Identifier Source: secondary_id
P-BCMA-ALLO1-001
Identifier Type: -
Identifier Source: org_study_id