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P-BCMA-ALLO1 CAR-T cells

Phase 1

Multiple Myeloma | Monoclonal antibody | Oncology |cbdMD, Inc.|Last Updated: Apr 24, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment275

FDA Designations

No designations recorded

Clinical trial landscape

P-BCMA-ALLO1 CAR-T cells · 1 trial · 1 indication

Phase 1 1
NCT04960579P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple MyelomaMultiple Myeloma
ACTIVE NOT_RECRUITING275 Analytics
PHASE1ACTIVE NOT_RECRUITING
P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase 1 Part 1: Assess the safety and maximum tolerated dose (MTD) of P-BCMA-ALLO1 based on dose limiting toxicities (DLT)
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.
Baseline through 36 months

Frequency and severity of adverse events, including cytokine release syndrome.

Phase 1b: The effect of cell dose and study arm
Baseline through 36 months

Overall response rate (ORR) based on International Myeloma Working Group (IMWG) uniform response criteria

Secondary Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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

NameTypeDescription
P-BCMA-ALLO1 CAR-T cellsBIOLOGICALAllogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
RimiducidDRUGSafety switch activator
MethotrexateDRUGAnti-metabolite
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites23

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...

Countries:United States
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Competitive Landscape -Multiple Myeloma 221 trials

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol/ Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Frequently asked questions about P-BCMA-ALLO1 CAR-T cells

What is P-BCMA-ALLO1 CAR-T cells used for?

P-BCMA-ALLO1 CAR-T cells is an investigational cell therapy being developed for the treatment of multiple myeloma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The therapy is being studied in patients with multiple myeloma, a type of blood cancer.

Who makes P-BCMA-ALLO1 CAR-T cells?

P-BCMA-ALLO1 CAR-T cells is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical research on this investigational therapy for multiple myeloma.

What phase is P-BCMA-ALLO1 CAR-T cells in?

P-BCMA-ALLO1 CAR-T cells is currently in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is actively enrolling participants, though recruitment is currently not active.

What clinical trials is P-BCMA-ALLO1 CAR-T cells in?

P-BCMA-ALLO1 CAR-T cells is being studied in a Phase 1 clinical trial registered as NCT04960579. This trial, titled 'P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma,' is active but not recruiting participants. The study is being conducted in the United States and has a planned enrollment of 275 participants.

Is P-BCMA-ALLO1 CAR-T cells the same as P-BCMA-ALLO1?

P-BCMA-ALLO1 CAR-T cells is the full name of the investigational therapy, and it is commonly referred to as P-BCMA-ALLO1 in clinical trial documentation. The therapy is an allogeneic CAR-T cell product targeting BCMA, a protein found on multiple myeloma cells.