CC-97540 (Ph 2) for Lupus Erythematosus, System… | Bristol-Myers Squibb Company | BiopharmaWatch

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CC-97540

Phase 2

Lupus Erythematosus, Systemic | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Jul 1, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker

Total Trials1

Total Enrollment89

FDA Designations

No designations recorded

Clinical trial landscape

CC-97540 · 4 trials · 9 indications

Phase 2 1Phase 1 3

Indication

NCT07015983A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)Lupus Erythematosus, Systemic

RECRUITING89 Analytics

PHASE2RECRUITING

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

Lupus Erythematosus, Systemic

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Study Endpoints

Primary Endpoints

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

Complete renal response (CRR) for participants with baseline lupus nephritis (LN)

Up to Month 60

Participants with drug-free DORIS remission

Up to month 60

CRR for participants with baseline LN

Up to month 60

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Study Design & Arms

AllocationNA

MaskingNONE

ModelSINGLE_GROUP

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
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
CC-97540	DRUG	Specified dose on specified days
Fludarabine	DRUG	Specified dose on specified days
Cyclophosphamide	DRUG	Specified dose on specified days
Lymphodepletion Chemotherapy	DRUG	Intravenous infusion of cyclophosphamide and fludarabine
Tocilizumab	DRUG	Specified dose on specified days

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Eligibility Criteria

Age Range16 Years to N/A

SexALL

Healthy VolunteersNo

Study Sites93

Inclusion Criteria: * Participants must meet EULAR/ACR 2019 criteria for SLE. * Participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months. * Participants must have active disease when signing ICF. Exclusion...

Countries:United StatesArgentinaAustriaBelgiumBrazilCanadaDenmarkFranceGermanyIsraelItalyJapanPolandPortugalSpainUnited Kingdom

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Recent Changes (Last 90 Days)

LOWJul 2, 2026NCT06220201lastUpdatePostDate: changed

LOWJul 2, 2026NCT06220201lastUpdatePostDate: changed

LOWJul 2, 2026NCT06220201lastUpdatePostDate: changed

LOWJul 2, 2026NCT06220201lastUpdatePostDate: changed

LOWJun 4, 2026NCT05869955lastUpdatePostDate: changed

LOWJun 4, 2026NCT05869955lastUpdatePostDate: changed

LOWJun 4, 2026NCT05869955lastUpdatePostDate: changed

LOWJun 4, 2026NCT05869955lastUpdatePostDate: changed

LOWJun 4, 2026NCT05869955lastUpdatePostDate: changed

LOWMay 26, 2026NCT07015983primaryCompletionDate: changed

LOWMay 26, 2026NCT06220201primaryCompletionDate: changed

LOWMay 26, 2026NCT05869955primaryCompletionDate: changed

LOWMay 24, 2026NCT07388277studyFirstPostDate: changed

LOWMay 24, 2026NCT07015983studyFirstPostDate: changed

LOWMay 24, 2026NCT06220201studyFirstPostDate: changed

LOWMay 24, 2026NCT05869955studyFirstPostDate: changed