Clinical Trials

Inclusion Criteria:

• Age ≥ 16 years.
• Meet EULAR/ACR 2019 criteria for SLE.
• Have an inadequate response to appropriate doses of GC and ≥ 2 IS therapies, used for at least 3 months each.
  • Inadequate response is defined as a lack of response, insufficient response, or lack of sustained response.
  • Intolerance or contraindication may be considered as inadequate response provided it is documented and confirmed acceptable by the Adjudication Committee.
• Active disease when signing ICF, defined as:
  • ≥ 1 BILAG A OR ≥ 1 BILAG B with history of SLE manifestations that would qualify for a BILAG A within the last 24 months
  • Laboratorial manifestations (at least one) to confirm diagnosis of SLE: Antinuclear antibody ≥ 1:160, anti-dsDNA, anti-Sm, SSA, SSB, or low complement (C3 or C4)
  • Participants who qualify based on active lupus glomerulonephritis must have a renal biopsy within the last 24 months indicating Class III or IV (alone or in combination with Class V). Repeat renal biopsy within 6 months prior to signing ICF may be required to ensure appropriateness for entry (eg, in the event of relapse or evidence of chronicity) to quantify ongoing activity and irreversible damage, at the discretion of the investigator or the adjudication committee.

Exclusion Criteria:

• Other diseases, conditions, or treatments that in the opinion of the investigator and/or adjudication committee may confound interpretation of the effects of CC-97540 in SLE.
• Uncontrolled systemic infections.
• Any one of the following cardiovascular conditions: Class III or IV heart failure as defined by the NYHA, unstable angina, or other clinically significant cardiac disease with compromise of normal cardiac function.
• Presence or history of unresolved clinically significant CNS pathology.
• 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.
• Prior treatment with CAR T cell therapy, genetically modified T cell therapy, or stem cell transplant. Washout periods may be required.
• Receipt of live vaccines within 6 weeks before CC-97540 administration.
• Participant has inadequate organ function, as determined by site’s local laboratory

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/18/2025. Questions regarding updates should be directed to the study team contact.