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Trial ID CA061-1011  |   NCT07015983

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)

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Summary

  • Phase 2
  • Male and Female Gender icon
  • 16+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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.

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Key Eligibility Criteria

Inclusion Criteria

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

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE.
          1. 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.
            1. IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant.
              1. Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, stem cell transplant or organ transplant.
                1. Participants must not have received live vaccines within 6 weeks before LDC (lymphodepleting chemotherapy) administration.
                  1. Participant must not have inadequate organ function.
                    1. Other protocol-defined inclusion/exclusion criteria apply.
                      Additional Information *

                      Treatment Options

                      Study Arms

                      ASSIGNED INTERVENTION

                      Study Arms

                      Experimental: Administration of CC-97540

                      ASSIGNED INTERVENTION
                      • Drug: CC-97540, Fludarabine, Cyclophosphamide

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