Clinical Trial 23614

• Overview

  Study Title:

  A Phase 2, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted NEXTCAR T Cells, in Participants with Active SLE (Including Lupus Nephritis) with Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants (Breakfree-SLE)

  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.

  Objective:

  Primary: To evaluate the efficacy of CC-97540 in participants with SLE Secondary: - To evaluate additional efficacy parameters in participants with SLE - To evaluate duration of response in patients with SLE - To assess the safety of CC-97540 in participants with SLE - Evaluation of effects of CC-97540 on SLE relevant autoantibodies and complement factors - To assess key PROs (SLE symptoms, functioning, and overall HRQoL) - To characterize cellular kinetics (ie, PK) of the expansion and persistence of CC-97540 in the peripheral blood Exploratory: - To measure HCRU - To evaluate the immune responses directed against CC-97540 - To evaluate kinetics of CC-97540 B cell depletion - To characterize B cell phenotype and/or clonality pre- and post-treatment - To evaluate changes in autoimmune inflammation

• Treatments

  Therapies:

  Cell Therapy; Chemotherapy (NOS)

  Medications:

  CC-97540 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

• Inclusion 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.

• Exclusion Criteria

  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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