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Zolacabtagene autoleucel

Phase 3

Systemic Sclerosis | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Aug 3, 2026

Target and mechanism

ModalitySmall molecule

Also known as CC-97540, BMS-986353

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC

Total Trials1

Total Enrollment92

FDA Designations

No designations recorded

Clinical trial landscape

Zolacabtagene autoleucel · 6 trials · 11 indications

Phase 3 1Phase 2 2Phase 1 3

Indication

NCT07335562A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic SclerosisSystemic Sclerosis

NOT YET_RECRUITING92 Analytics

PHASE3NOT YET_RECRUITING

A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis

Systemic Sclerosis

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Study Endpoints

Primary Endpoints

The absolute change from baseline in Forced Vital Capacity (FVC) in mL

At 12 months

Cohort 1 Part A: Number of participants with treatment-emergent adverse events (TEAEs)

Up to approximately Month 36

Cohort 1 Part A: Number of participants with serious AEs (SAEs)

Up to approximately Month 36

Cohort 1 Part A: Number of participants with AEs of special interest (AESI)

Up to approximately Month 36

Cohort 1 Part A: Number of participants with clinically significant laboratory abnormalities

Up to approximately Month 36

Cohort 1 Part B: Hematologic Complete Response (CR)

Up to approximately Month 6

Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission

At month 6

Safety of CC-97540 in ANCA-Associated Vasculitis

Study drug infusion (day 0) to 28 days post study drug infusion, assessed up to 12 months post study drug infusion.

The occurrence of DLT is the primary endpoint and will be assessed for all patients treated at the expansion dose.

Efficacy of CC-97540

Study drug infusion (day 0) to 28 days post study drug infusion, assessed up to 12 months post study drug infusion.

This will be determined by the percentage of participants in treatment-free remission defined as a BVASv3 of 0 off immunosuppressive therapy.

Number of participants with adverse events (AEs)

Up to week 104

Number of participants with serious adverse events (SAEs)

Up to week 104

Number of participants with adverse events of special interest (AESIs)

Up to week 104

Number of participants with laboratory test result abnormalities

Up to week 104

Number of participants with imaging abnormalities

Up to week 104

For Cohorts 1 and 2

Number of participants with dose-limiting toxicities (DLTs)

Up to week 104

Recommended Phase 2 dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period

Up to week 104

Number of participants with treatment-emergent adverse events (AEs) in each indication.

Up to 2 years after CC-97540 infusion

Number of participants with serious AEs (SAEs) in each indication.

Up to 2 years after CC-97540 infusion

Number of participants with AEs of special interest (AESI) in each indication.

Up to 2 years after CC-97540 infusion

Number of participants with laboratory abnormalities in each indication.

Up to 2 years after CC-97540 infusion

Number of participants with Dose Limiting Toxicities (DLT) in each indication.

Up to 2 years after CC-97540 infusion

Recommended Phase 2 Dose (RP2D) of CC-97540 in each indication.

Up to 2 years after CC-97540 infusion

Secondary Endpoints

The absolute change from baseline in Modified Rodnan Skin Score (mRSS)

At month 12

The absolute change from baseline in Quantitative Interstitial Lung Disease-Whole Lung (QILD-WL) score

Up to month 36

Time to progression, defined as the time from randomization to progressive disease

Approximately 54 months

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Study Design & Arms

AllocationRANDOMIZED

MaskingNONE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Arm A: BMS-986353	EXPERIMENTAL	-
Arm B: Standard of Care	EXPERIMENTAL	-
Cohort 1 Part A ITP	EXPERIMENTAL	-
Cohort 1 Part A AIHA	EXPERIMENTAL	-
Cohort 1 Part B	EXPERIMENTAL	-
Cohort 2	EXPERIMENTAL	-
Administration of CC-97540	EXPERIMENTAL	-
CC-97540	EXPERIMENTAL	Prior to receiving CC-97540, participants will undergo lymphodepleting chemotherapy. Lymphodepleting chemotherapy is the combination of cyclophosphamide and fludarabine and will be administered intravenously. CC-97540 will be infused intravenously on day 0 only.
Administration of CC-97540 (RMS arm)	EXPERIMENTAL	-
Administration of CC-97540 (PMS arm)	EXPERIMENTAL	-
Administration of CC-97540 (MG arm)	EXPERIMENTAL	-

Interventions

Name	Type	Description
BMS-986353	DRUG	Specified dose on specified days
Fludarabine	DRUG	Specified dose on specified days
Cyclophosphamide	DRUG	Specified dose on specified days
Tocilizumab	DRUG	Specified dose on specified days
Rituximab	DRUG	Specified dose on specified days
Nintedanib	DRUG	Specified dose on specified days
Fludarabine Phosphate	DRUG	Specified dose of specified days
CC-97540	DRUG	Specified dose on specified days
Lymphodepletion Chemotherapy	DRUG	Intravenous infusion of cyclophosphamide and fludarabine

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Eligibility Criteria

Age Range16 Years to N/A

SexALL

Healthy VolunteersNo

Study Sites56

Inclusion Criteria \- Participants must fulfill the 2013 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria for Systemic Sclerosis (SSc), and additionally have the following:. i) Positive Antinuclear Antibodies (ANA) with nucleolar pattern a...

Countries:United StatesBelgiumCanadaFranceGermanyItalyJapanSpainSwitzerlandUnited KingdomDenmarkArgentinaAustriaBrazilIsraelPolandPortugal

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Competitive Landscape -Systemic Sclerosis 29 trials

Top 20 of 21 competitors

Company	Ticker	Trials	Lead Phase	Drugs
AstraZeneca PLC	AZN	2	PHASE3	Anifrolumab
Bristol-Myers Squibb Company	BMY	2	PHASE3	BMS-986353, Fludarabine, Cyclophosphamide, Tocilizumab, Rituximab
Merck & Co., Inc.	MRK	1	PHASE2	Tulisokibart
Novartis AG Sponsored ADR	NVS	2	PHASE2	rapcabtagene autoleucel, rituximab
GSK plc Sponsored ADR	GSK	1	PHASE2	Belimumab
argenx SE Sponsored ADR	ARGX	1	PHASE2	Efgartigimod PH20
Cumberland Pharmaceuticals Inc.	CPIX	1	PHASE2	Ifetroban
Zura Bio Limited Class A	ZURA	1	PHASE2	Tibulizumab
Cabaletta Bio, Inc.	CABA	1	PHASE2	CABA-201
Artiva Biotherapeutics, Inc.	ARTV	1	PHASE2	Allogeneic NK Cells
Gilead Sciences, Inc.	GILD	1	PHASE1	KITE-363, Fludarabine, Cyclophosphamide
Kyverna Therapeutics, Inc.	KYTX	2	PHASE1	KYV-101, Cyclophosphamide, Fludarabine
CRISPR Therapeutics AG	CRSP	1	PHASE1	CTX112
Fate Therapeutics, Inc.	FATE	1	PHASE1	FT819, Fludarabine, Cyclophosphamide, Bendamustine
Nkarta, Inc.	NKTX	1	PHASE1	NKX019, Fludarabine, Cyclophosphamide
Adicet Bio Inc	ACET	1	PHASE1	ADI-001, Fludarabine, Cyclophosphamide
Allogene Therapeutics, Inc.	ALLO	1	PHASE1	ALLO-329, Cyclophosphamide, Fludarabine
Century Therapeutics, Inc.	IPSC	1	PHASE1	CNTY-101, IL-2, Lymphodepleting Chemotherapy
Precision BioSciences, Inc.	DTIL	2	PHASE1	BCMA/CD70-targetd CAR-T
TScan Therapeutics, Inc.	TCRX	1	-	Undisclosed

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Recent Changes (Last 90 Days)

MEDIUMAug 3, 2026NCT05869955Status: RECRUITING → ACTIVE_NOT_RECRUITING

MEDIUMAug 3, 2026NCT06220201Status: RECRUITING → ACTIVE_NOT_RECRUITING

LOWAug 3, 2026NCT07335562Status: RECRUITING → NOT_YET_RECRUITING

MEDIUMAug 3, 2026NCT05869955Status: RECRUITING → ACTIVE_NOT_RECRUITING

MEDIUMAug 3, 2026NCT06220201Status: RECRUITING → ACTIVE_NOT_RECRUITING

LOWAug 3, 2026NCT07335562Status: RECRUITING → NOT_YET_RECRUITING

LOWJul 24, 2026NCT06220201lastUpdatePostDate: changed

LOWJul 24, 2026NCT06220201lastUpdatePostDate: changed

LOWJul 2, 2026NCT06220201lastUpdatePostDate: changed

LOWJul 2, 2026NCT06220201lastUpdatePostDate: changed

LOWJul 2, 2026NCT06220201lastUpdatePostDate: changed

LOWJul 2, 2026NCT06220201lastUpdatePostDate: changed

LOWJun 16, 2026NCT07335562startDate: changed

LOWJun 16, 2026NCT07335562startDate: changed

LOWJun 16, 2026NCT07335562startDate: changed

LOWJun 16, 2026NCT07335562startDate: changed