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

Juno Therapeutics

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Lupus Erythematosus, Systemic; Lupus Nephritis

Treatments: Drug: Fludarabine; Drug: CC-97540; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07015983

2024-519278-37 (Other Identifier)

CA061-1011

Details and patient eligibility

About

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.

Enrollment: 89 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

Administration of CC-97540

Experimental group

Treatment:

Drug: Cyclophosphamide

Drug: CC-97540

Drug: Fludarabine