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Arlocabtagene Autoleucel

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment230

FDA Designations

No designations recorded

Clinical trial landscape

Arlocabtagene Autoleucel · 1 trial · 1 indication

Phase 2 1
NCT06297226Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple MyelomaMultiple Myeloma
RECRUITING230 Analytics
PHASE2RECRUITING
Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma
Multiple MyelomaUnlock trial analytics

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 to 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 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 Arlocabtagene Autoleucel

What is Arlocabtagene Autoleucel used for?

Arlocabtagene Autoleucel is an investigational cell therapy being studied for the treatment of multiple myeloma. It is a GPRC5D-directed CAR T cell therapy, also known as BMS-986393, developed by Bristol-Myers Squibb. It is currently in Phase 2 clinical development for adult participants with relapsed or refractory multiple myeloma.

What does Arlocabtagene Autoleucel target?

Arlocabtagene Autoleucel targets GPRC5D, a protein expressed on multiple myeloma cells. As a CAR T cell therapy, it is designed to direct a patient's own T cells to recognize and attack cancer cells that display GPRC5D. This mechanism is being evaluated in a Phase 2 clinical trial for relapsed or refractory multiple myeloma.

Who makes Arlocabtagene Autoleucel?

Arlocabtagene Autoleucel is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting a Phase 2 clinical trial of this investigational CAR T cell therapy for multiple myeloma, with the study currently recruiting participants.

What phase is Arlocabtagene Autoleucel in?

Arlocabtagene Autoleucel is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 2 trial is recruiting participants with relapsed or refractory multiple myeloma and is designed to evaluate the therapy's safety and efficacy in this patient population.

What clinical trials is Arlocabtagene Autoleucel in?

Arlocabtagene Autoleucel is being studied in a single Phase 2 clinical trial registered as NCT06297226. This study, titled 'Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma,' is currently recruiting and aims to enroll 230 participants across the United States, Australia, Canada, and Japan.

Is Arlocabtagene Autoleucel the same as BMS-986393?

Yes, Arlocabtagene Autoleucel is also known as BMS-986393. The clinical trial NCT06297226 refers to the drug by both names, describing it as a GPRC5D-directed CAR T cell therapy. This investigational treatment is being developed by Bristol-Myers Squibb for relapsed or refractory multiple myeloma.