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CC-95266

Phase 3

Multiple Myeloma | CAR-T | Oncology |Bristol-Myers Squibb Company|Trials Updated: Oct 6, 2026

CC-95266 development status

Highest phase Phase 3 (NCT06615479)

Phase scored for BMYPhase 1

Registered trials 4 across 2 sponsors since Dec 2020

CC-95266 target and mechanism

ModalityCAR-T

Also known as BMS-986393, Arlocabtagene autoleucel, arlo-cel

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC

Total Trials4

Total Enrollment987

FDA Designations

No designations recorded

CC-95266 clinical trials

CC-95266 · 4 trials · 2 indications

Phase 3 1Phase 2 1Phase 1 2

Indication

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)

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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

Number of participants with Adverse Events (AEs)

Up to 2 years after CC-95266 infusion

Number of participants with significant laboratory abnormalities

Up to 2 years after CC-95266 infusion

Number of participants with Dose Limiting Toxicities (DLTs)

Up to 2 years after CC-95266 infusion

Maximum Tolerated Dose (MTD)

Up to 2 years after CC-95266 infusion

Recommended Phase 2 Dose (RP2D)

Up to 2 years after CC-95266 infusion

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

Arm	Type	Description
Arm A	EXPERIMENTAL	-
Arm B	ACTIVE_COMPARATOR	-
Arlocabtagene Autoleucel Cohort 1	EXPERIMENTAL	-
Arlocabtagene Autoleucel Cohort 2	EXPERIMENTAL	-
Arm A: BMS-986393 + Alnuctamab	EXPERIMENTAL	-
Arm B: BMS-986393 + Mezigdomide	EXPERIMENTAL	-
Arm C: BMS-986393 + Iberdomide	EXPERIMENTAL	-
Arm D: BMS-986393 + Elranatamab	EXPERIMENTAL	-
Arm E: BMS-986393 + Mezigdomide and Dexamethasone	EXPERIMENTAL	-
Administration of CC-95266	EXPERIMENTAL	-

Interventions

Name	Type	Description
BMS-986393	DRUG	Specified dose on specified days
Cyclophosphamide	DRUG	Specified dose on specified days
Fludarabine	DRUG	Specified dose on specified days
Daratumumab	DRUG	Specified dose on specified days
Pomalidomide	DRUG	Specified dose on specified days
Dexamethasone	DRUG	Specified dose on specified days
Carfilzomib	DRUG	Specified dose on specified days
Arlocabtagene Autoleucel	BIOLOGICAL	Specified dose on specified days
Alnuctamab	DRUG	Specified dose on specified days
Mezigdomide	DRUG	Specified dose on specified days
Iberdomide	DRUG	Specified dose on specified days
Elranatamab	DRUG	Specified dose on specified days
CC-95266	DRUG	Specified dose on specified days
Bendamustine	DRUG	Specified 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

Top 20 of 25 competitors

Company	Ticker	Trials	Lead Phase	Drugs
AbbVie, Inc.	ABBV	18	PHASE3	Venetoclax, Etentamig, Elotuzumab, TNB-383B, ABBV-453
Johnson & Johnson	JNJ	36	PHASE3	Talquetamab, Teclistamab, Bortezomib, Cilta-cel, Daratumumab
Bristol-Myers Squibb Company	BMY	21	PHASE3	Iberdomide, Lenalidomide, Mezigdomide, idecabtagene vicleucel, Arlocabtagene autoleucel
Takeda Pharmaceutical Co. Ltd. Sponsored ADR	TAK	6	PHASE3	Gammagard Liquid, Ixazomib
GSK plc Sponsored ADR	GSK	26	PHASE3	Belantamab mafodotin, GSK3174998, Feladilimab, Dostarlimab, GSK2857916 with Pomalidomide and Dexamethasone
Regeneron Pharmaceuticals, Inc.	REGN	11	PHASE3	linvoseltamab, REGN17372, Fianlimab, Cemiplimab, REGN7945
Pfizer Inc.	PFE	14	PHASE3	Elranatamab, Axitinib, Bosutinib, Crizotinib, Palbociclib
Sanofi SA Sponsored ADR	SNY	17	PHASE3	Isatuximab, Pegenzileukin, SAR439459, Belumosudil, SAR446523
AstraZeneca PLC	AZN	8	PHASE3	AZD0120, GC012F, AZD0305, AZD4045
Gilead Sciences, Inc.	GILD	4	PHASE3	anitocabtagene-autoleucel
Karyopharm Therapeutics, Inc.	KPTI	7	PHASE3	Selinexor
Grifols, S.A. Sponsored ADR Class B	GRFS	1	PHASE3	Xembify
Hoffmann-La Roche	RHHBY	10	PHASE3	Cevostamab, Tocilizumab, XmAb24306, RO7875913, RO7851624
C4 Therapeutics, Inc.	CCCC	3	PHASE2	cemsidomide
Cellectar Biosciences, Inc.	CLRB	1	PHASE2	Iopofosine I-131
GeoVax Labs, Inc.	GOVX	1	PHASE2	GEO-CM04S1
Incyte Corporation	INCY	2	PHASE1	Ruxolitinib
Moderna, Inc.	MRNA	2	PHASE1	mRNA-2808
BeOne Medicines Ltd. Sponsored ADR	ONC	1	PHASE1	Sonrotoclax
Caribou Biosciences, Inc.	CRBU	2	PHASE1	CB-011

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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 CC-95266

What is CC-95266 used for?

CC-95266 is an investigational cell therapy being studied for the treatment of relapsed and/or refractory multiple myeloma, a cancer of plasma cells in the bone marrow. It is being developed by Bristol-Myers Squibb and is in Phase 1 clinical development.

Who is developing CC-95266?

CC-95266 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is the sponsor of the clinical program evaluating the therapy in multiple myeloma.

What phase is CC-95266 in?

CC-95266 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 1 program has completed one trial with 130 participants.

What clinical trials is CC-95266 in?

CC-95266 has been evaluated in one clinical trial, NCT04674813, titled A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma. The Phase 1 trial enrolled 130 participants in the United States and is now completed.

What type of therapy is CC-95266?

CC-95266 is a CAR-T cell therapy, a type of treatment in which a patient's T cells are engineered to target cancer cells. It is being studied in multiple myeloma, a hematologic malignancy, by Bristol-Myers Squibb.

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