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Arlocabtagene autoleucel

Phase 3

Relapsed or Refractory Multiple Myeloma (RRMM) | CAR-T | Oncology |Bristol-Myers Squibb Company|Trials Updated: Oct 6, 2026

Arlocabtagene autoleucel development status

Highest phase Phase 3
Registered trials 4 across 2 sponsors since Dec 2020

Arlocabtagene autoleucel target and mechanism

Target class-Cel (Cell Tx)
ModalityCAR-T

Also known as BMS-986393, GPRC5D CAR T cells, Arlo-cel

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials3
Total Enrollment857

FDA Designations

No designations recorded

Arlocabtagene autoleucel clinical trials

Arlocabtagene autoleucel · 3 trials · 2 indications

Phase 3 1Phase 2 1Phase 1 1
NCT06615479A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)Relapsed or Refractory Multiple Myeloma (RRMM)
RECRUITING440 Analytics
PHASE3RECRUITING
A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)
Relapsed or Refractory Multiple Myeloma (RRMM)Unlock trial analytics

Study Endpoints

Primary Endpoints

Progression Free Survival (PFS)
Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negativity in complete response (CR)
Up to 1 year after the last participant is randomized
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)

Incidence of adverse events (AEs)
Up to 2 years
Incidence of serious adverse events (SAEs)
Up to 2 years
Incidence of adverse events of special interest (AESI)
Up to 2 years
Incidence of AEs leading to discontinuation
Up to 2 years
Number of Deaths
Up to 2 years
Establish recommended Phase 2 dose (RP2D)
Up to 2 years

Secondary Endpoints

Overall survival (OS)
Up to 5 years after the last participant is randomized
Overall response rate (ORR)
Up to 5 years after the last participant is randomized
Minimal residual disease (MRD)-negative status
Up to 5 years after the last participant is randomized
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BACTIVE_COMPARATOR -
Arlocabtagene Autoleucel Cohort 1EXPERIMENTAL -
Arlocabtagene Autoleucel Cohort 2EXPERIMENTAL -
Arm A: BMS-986393 + AlnuctamabEXPERIMENTAL -
Arm B: BMS-986393 + MezigdomideEXPERIMENTAL -
Arm C: BMS-986393 + IberdomideEXPERIMENTAL -
Arm D: BMS-986393 + ElranatamabEXPERIMENTAL -
Arm E: BMS-986393 + Mezigdomide and DexamethasoneEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986393DRUGSpecified dose on specified days
CyclophosphamideDRUGSpecified dose on specified days
FludarabineDRUGSpecified dose on specified days
DaratumumabDRUGSpecified dose on specified days
PomalidomideDRUGSpecified dose on specified days
DexamethasoneDRUGSpecified dose on specified days
CarfilzomibDRUGSpecified dose on specified days
Arlocabtagene AutoleucelBIOLOGICALSpecified dose on specified days
AlnuctamabDRUGSpecified dose on specified days
MezigdomideDRUGSpecified dose on specified days
IberdomideDRUGSpecified dose on specified days
ElranatamabDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites141

Inclusion Criteria * Participants must have relapsed or refractory multiple myeloma (RRMM). * Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monocl...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaCzechiaDenmarkFinlandFranceGermanyGreeceHungaryIsraelItalyJapanNetherlandsNorwayPolandPortugalRomaniaSaudi ArabiaSingaporeSouth KoreaSpainSwedenSwitzerlandTaiwanTurkey (Türkiye)United Kingdom
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Competitive Landscape -Multiple Myeloma 340 trials (matched to "Relapsed or Refractory Multiple Myeloma (RRMM)")

Recent Changes (Last 90 Days)

LOWOct 6, 2026NCT06297226lastUpdatePostDate: changed
LOWOct 6, 2026NCT06297226lastUpdatePostDate: changed
LOWSep 16, 2026NCT06615479lastUpdatePostDate: changed
LOWSep 16, 2026NCT06615479lastUpdatePostDate: changed
LOWSep 16, 2026NCT06615479lastUpdatePostDate: changed
LOWSep 16, 2026NCT06615479lastUpdatePostDate: changed
LOWSep 15, 2026NCT06297226primaryCompletionDate: changed
LOWSep 15, 2026NCT06297226primaryCompletionDate: changed
LOWSep 15, 2026NCT06297226primaryCompletionDate: changed
MEDIUMSep 14, 2026NCT06121843Enrollment: 147 → 187
LOWAug 19, 2026NCT06615479lastUpdatePostDate: changed
LOWAug 19, 2026NCT06615479lastUpdatePostDate: changed
LOWAug 19, 2026NCT06615479lastUpdatePostDate: changed

Frequently asked questions about Arlocabtagene autoleucel

What is Arlocabtagene autoleucel?

Arlocabtagene autoleucel is an investigational CAR T cell therapy being developed by Bristol-Myers Squibb for multiple myeloma, including relapsed or refractory multiple myeloma. It is also known as BMS-986393. It is a GPRC5D-directed CAR T cell therapy and is currently in clinical development.

What is Arlocabtagene autoleucel used for?

Arlocabtagene autoleucel is being studied for the treatment of multiple myeloma, including relapsed or refractory multiple myeloma (RRMM). It is an investigational therapy and has not been approved for any indication.

What does Arlocabtagene autoleucel target?

Arlocabtagene autoleucel targets GPRC5D. It is a GPRC5D-directed CAR T cell therapy, meaning the CAR T cells are engineered to recognize and attack cells expressing GPRC5D.

Who is developing Arlocabtagene autoleucel?

Arlocabtagene autoleucel is being developed by Bristol-Myers Squibb Company (ticker: BMY). The company is running clinical trials of the therapy in multiple myeloma.

What phase is Arlocabtagene autoleucel in?

Arlocabtagene autoleucel is in Phase 2 development. A Phase 3 trial is also recruiting, but the overall development stage is Phase 2. It is investigational and has not been approved by the FDA.

What clinical trials is Arlocabtagene autoleucel in?

Arlocabtagene autoleucel is being studied in three recruiting trials: NCT06615479 (Phase 3, QUINTESSENTIAL-2), NCT06297226 (Phase 2), and NCT06121843 (Phase 1). All are in multiple myeloma or relapsed/refractory multiple myeloma.

Is Arlocabtagene autoleucel the same as BMS-986393?

Yes, Arlocabtagene autoleucel is also known as BMS-986393. Both names refer to the same GPRC5D-directed CAR T cell therapy being developed by Bristol-Myers Squibb.