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

Phase 2

Recruiting

• Conditions: Lupus Erythematosus, Systemic; Lupus Nephritis
• Interventions: Drug: CC-97540; Drug: Fludarabine; Drug: Cyclophosphamide

• Registration Number: NCT07015983
• Lead Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-30
• Study First Submitted QC: 2025-06-06
• Study First Posted: 2025-06-11
• Status Verified: 2025-07
• Study Start: 2025-07-14
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-07-30
• Primary Completion: 2028-05-17
• Study Completion: 2032-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Not provided

Exclusion Criteria

• Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE.
• Uncontrolled or clinically significant cardiovascular conditions or CNS pathology participants must not have prior history of malignancies or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years, except for some non-invasive malignancies.
• IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant during participation in the study.
• Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, or stem cell transplant. Washout periods may be required.
• Participants must not have received live vaccines within 6 weeks before CC-97540 administration.
• Participant must not have inadequate organ function.
• Other protocol defined inclusion/exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Administration of CC-97540	CC-97540	-
Administration of CC-97540	Fludarabine	-
Administration of CC-97540	Cyclophosphamide	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission	At month 6

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Systemic Lupus International Collaborating Clinics (SLICC) damage	Up to month 60
Percentage of participants achieving maintenance of LLDAS	Up to month 60
Percentage of participants achieving maintenance of SRI-4	Up to month 60
Time from first response to loss of response for drug-free DORIS remission	Up to month 60
Time from first response to loss of response for LLDAS	Up to month 60
Time from baseline to first drug-free DORIS remission	Up to month 60
Time from baseline to LLDAS	Up to month 60
Time from baseline to SRI-4	Up to month 60
Duration of drug-free status	Up to month 60
Percentage of participants achieving DORIS remission regardless of drug-free status	Up to month 60
Glucocorticoid used post-infusion for SLE treatment	Up to month 60
Change of serum autoantibodies from baseline	Up to month 60
Change in complement factor (C3 and C4) levels from baseline	Up to month 60
Change from baseline in patient reported outcomes (PRO) as assessed by FACIT-Fatigue	Up to month 60
Change from baseline in PRO as assessed by SF 36 v2 Acute	Up to month 60
Change from baseline in PRO as assessed by EQ-5D-5L	Up to month 60
Change from baseline in PRO as assessed by Patient Global Impression of Severity (PGI-S) Pain	Up to month 60
Change from baseline in PRO as assessed by PGI-S Fatigue	Up to month 60
Patient Global Impression of Change (PGI-C) Pain	Up to month 60
PGI-C Fatigue	Up to month 60
Percentage of participants achieving maintenance of drug-free DORIS remission	Up to month 60
Change from baseline in estimated glomerular filtration rate (eGFR)	Up to month 60
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
Modified CRR for participants with baseline LN	Up to month 60
Number of participants achieving Lupus Low Disease Activity State (LLDAS) with baseline Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥6	Up to month 60
Number of participants achieving SLE Responder Index (SRI) - 4 with baseline SLEDAI ≥6	Up to month 60
Number of participants with flares as assessed by SLEDAI flare index	Up to month 60
Severity of participants with flares as assessed by SLEDAI flare index	Up to month 60
Change from baseline in proteinuria	Up to month 60
Time from first response to loss of response for SRI-4	Up to month 60

Trial Locations

Locations (71)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Atlantic Health System Overlook Medical Center; 🇺🇸 Summit, New Jersey, United States

Local Institution - 0065; 🇺🇸 Charlotte, North Carolina, United States

Baylor Scott and White Research Institute; 🇺🇸 Dallas, Texas, United States

Local Institution - 0009; 🇺🇸 Birmingham, Alabama, United States

Local Institution - 0038; 🇺🇸 Los Angeles, California, United States

Local Institution - 0051; 🇺🇸 Los Angeles, California, United States

Local Institution - 0035; 🇺🇸 Palo Alto, California, United States

Local Institution - 0006; 🇺🇸 Jacksonville, Florida, United States

Local Institution - 0002; 🇺🇸 Miami, Florida, United States

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