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  • NCT07015983

Recruiting

A Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE) - CA061-1011

Oppdatert: 8 september, 2025   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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Vis detaljer

  • Phase 2

    Fase

  • Kjønn

  • 16+

    Aldersgruppe

  • 52

    Sted(er)

  • Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: Administration of CC-97540
Drug: CC-97540, Fludarabine, Cyclophosphamide

Nøkkelkriterier for kvalifikasjon

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.

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MLTNO2000046