A Phase 1b, Open-label, Pilot Study of CLN-978 for the Treatment of Moderate to Severe Systemic Lupus Erythematosus (SLE)
Cullinan Therapeutics Inc.
Summary
Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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 immunosup…
Interventions
- DrugCLN-978
Specified dose on specified days
Locations (15)
- Cullinan Investigative SiteAvondale, Arizona
- Cullinan Investigative SiteTucson, Arizona
- Cullinan Investigative SiteOrlando, Florida
- Cullinan Investigative SiteIowa City, Iowa
- Cullinan Investigative SiteNew York, New York
- Cullinan Investigative SiteRochester, New York