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Arlocabtagene Autoleucel

Phase 2

Multiple Myeloma | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: May 28, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment230
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06297226Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple MyelomaPHASE2 RECRUITING 230 — — Mar 21, 2024Jun 30, 2032May 28, 202652 United States, Australia +2
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Study Endpoints
Primary Endpoints
Cohort 1: Best overall response (BOR) of partial response (PR) or better
Up to approximately 5 years

The number and percent of participants achieving BOR of partial response (PR) or better in quadruple class exposed participants received at least 4 prior lines of therapy (LOT)

Secondary Endpoints
BOR of partial response (PR) or better
Up to approximately 5 years
Best overall response (BOR) of complete response (CR) including stringent complete response (sCR)
Up to approximately 5 years
Minimal residual disease (MRD) negative status
Up to approximately 5 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arlocabtagene Autoleucel Cohort 1EXPERIMENTAL -
Arlocabtagene Autoleucel Cohort 2EXPERIMENTAL -
Interventions
NameTypeDescription
Arlocabtagene AutoleucelBIOLOGICALSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites52

Inclusion Criteria * Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria. * Received at least 4 classes of MM treatment \[including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, anti-BCMA therapy, and at least 3 prior li...

Countries:United StatesAustraliaCanadaJapan
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Competitive Landscape -Multiple Myeloma 228 trials
CompanyTickerTrialsLead PhaseDrugs
Johnson & JohnsonJNJ30PHASE3Daratumumab, Lenalidomide, Bortezomib, Dexamethasone, Cilta-cel
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax, Etentamig, Carfilzomib
Bristol-Myers Squibb CompanyBMY19PHASE3Mezigdomide, Carfilzomib, Dexamethasone, Daratumumab, Bortezomib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%, Clarithromycin, Dexamethasone, Ixazomib, Pomalidomide
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib, Daratumumab
Regeneron Pharmaceuticals, Inc.REGN12PHASE3Linvoseltamab, Daratumumab, Carfilzomib, Dexamethasone, Pomalidomide
Pfizer Inc.PFE12PHASE3Elranatamab, Lenalidomide, Elotuzumab, Pomalidomide, Dexamethasone
Sanofi SA Sponsored ADRSNY18PHASE3Isatuximab, 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, Bortezomib
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040 /kg + G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone, cemsidomide, Elranatamab
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
Eli Lilly and CompanyLLY1PHASE1LOXO-338, Pirtobrutinib
Moderna, Inc.MRNA2PHASE1mRNA-2808
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT06297226lastUpdatePostDate: changed
LOWMay 29, 2026NCT06297226lastUpdatePostDate: changed
LOWMay 29, 2026NCT06297226lastUpdatePostDate: changed
LOWMay 26, 2026NCT06297226primaryCompletionDate: changed
LOWMay 24, 2026NCT06297226studyFirstPostDate: changed