Multiple MyelomaPhase 1MMNCT04960579
P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma
A Phase 1 study testing P-BCMA-ALLO1 CAR-T cells, Rimiducid and Methotrexate in people with Multiple Myeloma, run by Poseida Therapeutics, Inc. at 23 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- P-BCMA-ALLO1 CAR-T cells, Rimiducid and Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 23 sitesUnited States
- Study dates
- 5 May 2022to Mar 2042
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
- Has CNS metastases or symptomatic CNS involvement of their myeloma.
- Has a history of severe immediate hypersensitivity reaction to any of the agents used in this study.
- 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.
- 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.
- Has received radiation within 1 week of initiating conditioning LD therapy.
- Administration of a live vaccine within the last 28 days prior to administration of LD therapy.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Emory University
Atlanta, Georgia, 30322
Blood Marrow and Transplant Group of Georgia
Atlanta, Georgia, 30342
Sarah Cannon Research Institute - St. David's South Austin Medical Center
Austin, Texas, 78704
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-1350
City of Hope
Chicago, Illinois, 60099
University of Cincinnati
Cincinnati, Ohio, 45221
Cleveland Clinic
Cleveland, Ohio, 44195
Wayne State - Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope
Goodyear, Arizona, 85338
Hackensack Meridian Health
Hackensack, New Jersey, 07601
Houston Methodist Research Institute
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66160
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mount Sinai
New York, New York, 10029
University of Oklahoma, Health Sciences Center
Oklahoma City, Oklahoma, 73104
Advocate Aurora Health
Park Ridge, Illinois, 66068
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4238
Sarah Cannon Research Institute - Methodist Healthcare
San Antonio, Texas, 78229
University of California San Diego
San Diego, California, 92093
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-BCMA-ALLO1 in Subjects With Relapsed / Refractory Multiple Myeloma (MM)
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).
Read the detailed description
Phase 1/1b study: Phase 1 Part 1 is a weight-based dose escalation following a 3+3 design of dose-escalating cohorts. Phase 1 Part 2 includes administration at fixed doses. After enrollment, subjects may receive a lymphodepletion therapy regimen before administration of allogeneic CAR-T cells, administered as a single or multiple dose(s). Treated subjects will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated. Phase 1b of the study will undergo further expansion of cohorts/arms from Phase 1 Parts 1 or 2 or an intermediate dose between cohort levels.
- Conditions
- Multiple Myeloma
- Being tested
- P-BCMA-ALLO1 CAR-T cells, Rimiducid, Methotrexate
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-BCMA-ALLO1 CAR-T cellsBiological
Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
RimiducidDrug
Safety switch activator
MethotrexateDrug
Anti-metabolite
| Study group | Role | What they receive |
|---|---|---|
| P-BCMA-ALLO1 CAR-T cells (Arm S) | Experimental | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen S.
Rimiducid may be administered as indicated. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm F) | Experimental | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen F.
Rimiducid may be administered as indicated. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm N) | Experimental | Single weight-based IV administration of P-BCMA-ALLO1. Rimiducid may be administered as indicated. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm P1) | Experimental | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P1.
Rimiducid may be administered as indicated. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm P2) | Experimental | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P2.
Rimiducid may be administered as indicated. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm R) | Experimental | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen R.
Rimiducid may be administered as indicated. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm RS) | Experimental | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RS.
Rimiducid may be administered as indicated. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm C) | Experimental | Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen C.
Rimiducid may be administered as indicated. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm160) | Experimental | 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. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm480) | Experimental | 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. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm P1.5) | Experimental | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen P1.5.
Rimiducid may be administered as indicated. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm RP1) | Experimental | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP1.
Rimiducid may be administered as indicated. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm RP1.5) | Experimental | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP1.5.
Rimiducid may be administered as indicated. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm RP2) | Experimental | Single weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen RP2.
Rimiducid may be administered as indicated. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm CP1) | Experimental | Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP1.
Rimiducid may be administered as indicated. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm CP1.5) | Experimental | Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP1.5.
Rimiducid may be administered as indicated. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm CP2) | Experimental | Cyclic weight-based IV administration of P-BCMA-ALLO1 following conditioning chemotherapy regimen CP2.
Rimiducid may be administered as indicated. Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid |
| P-BCMA-ALLO1 CAR-T cells (Arm MP1.5) | Experimental | Single weight based IV administration of P-BCMA-ALLO1 and methotrexate following conditioning chemotherapy regimen MP1.5 Rimiducid may be administered as indicated Receives: Biological: P-BCMA-ALLO1 CAR-T cells; Drug: Rimiducid; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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
Measured: Baseline through 36 months
Secondary outcomes (3)
The safety of P-BCMA-ALLO1
Incidence and severity of treatment-emergent adverse events
Measured: Baseline through 15 years
The anti-myeloma effect of P-BCMA-ALLO1 (ORR) in Phase 1 Parts 1 and 2
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)
Measured: Baseline through 15 years
Safety and Efficacy (anti-myeloma effect) will be used to guide the selection of RP2D
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)
Measured: Baseline through 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start5 May 2022
- Primary completionMar 2029 (estimated)
- Study completionMar 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poseida Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche-Genentech
- Responsible party
- Sponsor
- Investigators
- Maika Onishi, M.D., Study director, Senior Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960579
- Sponsor's protocol ID
- P-BCMA-ALLO1-001
- Other IDs
- XO44788
- Acronym
- MM
- Status last verified
- Apr 2026
- First submitted
- 24 Jun 2021
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41285709
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-BCMA-ALLO1 in Subjects With Relapsed / Refractory Multiple Myeloma (MM)
- ClinicalTrials.gov ID
- NCT04960579
- Acronym / sponsor ID
- MM / P-BCMA-ALLO1-001
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Poseida Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Roche-Genentech
- Study start
- 5 May 2022 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2042 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Phase 1/1b study: Phase 1 Part 1 is a weight-based dose escalation following a 3+3 design of dose-escalating cohorts. Phase 1 Part 2 includes administration at fixed doses. After enrollment, subjects may receive a lymphodepletion therapy regimen before administration of allogeneic CAR-T cells, administered as a single or multiple dose(s). Treated subjects will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated. Phase 1b of the study will undergo further expansion of cohorts/arms from Phase 1 Parts 1 or 2 or an intermediate dose between cohort levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| P-BCMA-ALLO1 CAR-T cells (Arm S) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidSingle 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) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidSingle 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) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidSingle weight-based IV administration of P-BCMA-ALLO1. Rimiducid may be administered as indicated. |
| P-BCMA-ALLO1 CAR-T cells (Arm P1) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidSingle 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) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidSingle 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) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidSingle 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) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidSingle 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) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidCyclic 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) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidSingle 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) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidSingle 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) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidSingle 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) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidSingle 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) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidSingle 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) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidSingle 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) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidCyclic 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) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidCyclic 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) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: RimiducidCyclic 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) | Experimental | Biological: P-BCMA-ALLO1 CAR-T cells, Drug: Rimiducid, Drug: MethotrexateSingle weight based IV administration of P-BCMA-ALLO1 and methotrexate following conditioning chemotherapy regimen MP1.5 Rimiducid may be administered as indicated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P-BCMA-ALLO1 CAR-T cellsAllogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy | Biological | P-BCMA-ALLO1 CAR-T cells (Arm C), P-BCMA-ALLO1 CAR-T cells (Arm CP1), P-BCMA-ALLO1 CAR-T cells (Arm CP1.5), P-BCMA-ALLO1 CAR-T cells (Arm CP2), P-BCMA-ALLO1 CAR-T cells (Arm F), P-BCMA-ALLO1 CAR-T cells (Arm MP1.5), P-BCMA-ALLO1 CAR-T cells (Arm N), P-BCMA-ALLO1 CAR-T cells (Arm P1), P-BCMA-ALLO1 CAR-T cells (Arm P1.5), P-BCMA-ALLO1 CAR-T cells (Arm P2), P-BCMA-ALLO1 CAR-T cells (Arm R), P-BCMA-ALLO1 CAR-T cells (Arm RP1), P-BCMA-ALLO1 CAR-T cells (Arm RP1.5), P-BCMA-ALLO1 CAR-T cells (Arm RP2), P-BCMA-ALLO1 CAR-T cells (Arm RS), P-BCMA-ALLO1 CAR-T cells (Arm S), P-BCMA-ALLO1 CAR-T cells (Arm160), P-BCMA-ALLO1 CAR-T cells (Arm480) |
| RimiducidSafety switch activator | Drug | P-BCMA-ALLO1 CAR-T cells (Arm C), P-BCMA-ALLO1 CAR-T cells (Arm CP1), P-BCMA-ALLO1 CAR-T cells (Arm CP1.5), P-BCMA-ALLO1 CAR-T cells (Arm CP2), P-BCMA-ALLO1 CAR-T cells (Arm F), P-BCMA-ALLO1 CAR-T cells (Arm MP1.5), P-BCMA-ALLO1 CAR-T cells (Arm N), P-BCMA-ALLO1 CAR-T cells (Arm P1), P-BCMA-ALLO1 CAR-T cells (Arm P1.5), P-BCMA-ALLO1 CAR-T cells (Arm P2), P-BCMA-ALLO1 CAR-T cells (Arm R), P-BCMA-ALLO1 CAR-T cells (Arm RP1), P-BCMA-ALLO1 CAR-T cells (Arm RP1.5), P-BCMA-ALLO1 CAR-T cells (Arm RP2), P-BCMA-ALLO1 CAR-T cells (Arm RS), P-BCMA-ALLO1 CAR-T cells (Arm S), P-BCMA-ALLO1 CAR-T cells (Arm160), P-BCMA-ALLO1 CAR-T cells (Arm480) |
| MethotrexateAnti-metabolite | Drug | P-BCMA-ALLO1 CAR-T cells (Arm MP1.5) |
Primary outcome
Phase 1 Part 1: Assess the safety and maximum tolerated dose (MTD) of P-BCMA-ALLO1 based on dose limiting toxicities (DLT)
Time frame: Baseline through Day 28
Rate of 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.
Time frame: Baseline through 36 months
Frequency and severity of adverse events, including cytokine release syndrome.
Phase 1b: The effect of cell dose and study arm
Time frame: Baseline through 36 months
Overall response rate (ORR) based on International Myeloma Working Group (IMWG) uniform response criteria
3 secondary outcomes
The safety of P-BCMA-ALLO1
Time frame: Baseline through 15 years
The anti-myeloma effect of P-BCMA-ALLO1 (ORR) in Phase 1 Parts 1 and 2
Time frame: Baseline through 15 years
Safety and Efficacy (anti-myeloma effect) will be used to guide the selection of RP2D
Time frame: Baseline through 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Derived from this study: PubMed 41285709Tseng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maika Onishi, M.D. study director
Senior Medical Director
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing P-BCMA-ALLO1 CAR-T cells, Rimiducid and Methotrexate in people with Multiple Myeloma, run by Poseida Therapeutics, Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 Part 1: Assess the safety and maximum tolerated dose (MTD) of P-BCMA-ALLO1 based on dose limiting toxicities (DLT) (time frame: Baseline through Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04960579, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.