A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
Trial Parameters
Brief Summary
Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).
Eligibility Criteria
Inclusion Criteria: * Diagnosis of SLE at least 24 weeks prior to Screening and meet 2019 EULAR / ACR Classification Criteria at screening. * Presence of one or more of the following autoantibodies documented during screening or in the previous 12 months before screening: positive anti-nuclear antibody (ANA) test (≥1:80); anti dsDNA above the upper limit of normal (ULN); anti-Sm above the ULN. * Active SLE disease, as demonstrated by a SLEDAI total score ≥6 at screening. * Inadequate response to at least 2 of the following treatments: oral corticosteroid, antimalarials, conventional immunosuppressants, or biologics. At least one of the failed treatments should be an immunosuppressive or biologic standard-of care agent. * If on corticosteroid and/or antimalarial, the dose must be stable prior to day 1. * Laboratory parameters including the following: * Absolute lymphocyte count (ALC) ≥0.5 x 109/L * Peripheral B cell count ≥25 cells/µL * Absolute neutrophil count (ANC) ≥1.0 x 109/L * Hem