A Phase 1b, Open-label, Pilot Study of CLN-978 for the Treatment of Moderate to Severe Systemic Lupus Erythematosus (SLE)
Date de révision : 08/05/2026
4 participants
Homme Femme
A partir de 18 ans
Critères :
Critères d'inclusion :
- Age 18 to 70 years.
- 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.
- Patient must understand the purpose of the study and study procedures and can provide signed informed consent.
- Diagnosis of SLE at least 24 weeks prior to Screening visit and meet the 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 or equivalent in reported units according to the laboratory standard); anti-dsDNA above the upper limit of normal (ULN); anti-Sm above the ULN.
- Active SLE disease, as demonstrated by a hSLEDAI total score ≥6 at screening.
- Inadequate response to at least 2 of the following treatment: oral corticosteroid, antimalarial, conventional immunosuppressant or biologic. At least one of the failed treatments should be an immunosuppressive or biologic standard of care agent.
- If on glucocorticoids/corticosteroids, the dose should not be increased during the Screening period (unless needed as rescue treatment).
- If on antimalarials, the dose should be stable prior to the Screening visit and remain stable during the Screening period.
- 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 the Chronic Kidney Disease Epidemiology Collaboration [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
Critères d'exclusion :
- Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren’s syndrome is allowed.
- 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.
- 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.
- Considered at high risk for thrombosis.
- Rapidly progressive glomerulonephritis, and/or urine protein/creatinine >3 mg/mg (339 mg/mmol).
- Active severe neuropsychiatric/CNS manifestations of SLE.
- Evidence of hepatitis B, hepatitis C (HCV) infection, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.
- History of splenectomy.
- Prior treatment with the following: • Cellular therapy 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 prior to Day 1 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.
Lieux et contacts
Informations pratiques pour participer à cet essai.
Contacts
Sites des essais
Adresse
Centre Hospitalier Universitaire De Toulouse
31059 Toulouse Cedex 9 France
Centre Hospitalier Universitaire De Saint Etienne
42055 St Etienne Cedex 2 France
Comment postuler ?
Pour participer à cet essai clinique, veuillez contacter la personne responsable de l'étude. Vous trouverez ses coordonnées dans la section "Lieux et contacts", puis "Contacts".