Tests CLN-978 in adults with moderate to severe systemic lupus

Trial details

Who runs it

Cullinan Therapeutics Inc.

Trial code

NCT06613360EU 2024-518780-36-00

Record updated

26 October 2026

Original description

Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).Read full original descriptionShow less

A Phase 1b, Open-label, Pilot Study of CLN-978 for the Treatment of Moderate to Severe Systemic Lupus Erythematosus (SLE)

Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).

Inclusion: 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; Hemoglobin ≥8 g/dL; Platelet count ≥75 x 109/L; Estimated glomerular filtration rate (eGFR) (based on CKD-EPI formula) ≥30 mL/min/1.73m2; Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN; Part B only: For patients who were treated in Part A and did not experience dose-limiting toxicity (DLT) or discontinue CLN-978 treatment due to AEs are eligible for retreatment at a higher dose or longer schedule in Part B if they otherwise meet eligibility criteria and at least 90 days have passed since the last dose of CLN-978.

Exclusion: Prior treatment with the following:; Cellular or gene therapy product directed at any target; Investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1; Any anti-CD19 or anti-CD20 therapy less than 3 months prior to Day 1; Non-biologic DMARD within 14 days prior to Day 1; Cyclophosphamide within 1 month or a biologic immunomodulating therapy during 2 months prior to Day 1; Live or attenuated vaccine within 28 days prior to screening or during screening; Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including SARS-CoV-2 infection, within 14 days before Day 1; Active or latent tuberculosis (TB) evidenced by a positive or indeterminant Interferon Gamma Release Assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication of TB; Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren's syndrome is allowed; Considered at high risk for thrombosis; Evidence of hepatitis B, hepatitis C (HCV) infection, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection; History of splenectomy; Any condition for which, in the opinion of the Investigator and/or Sponsor, would not be in the best interest of the patient to participate in the study or that could prevent, limit, or confound any protocol-defined assessment; Rapidly progressive glomerulonephritis, and/or urine protein/creatinine >3 mg/mg (339 mg/mmol); Active severe neuropsychiatric/CNS manifestations of SLE.

ClinicalTrials.gov NCT06613360 · EU CTIS 2024-518780-36-00