Phase
Condition
Lupus
Systemic Lupus Erythematosus
Cutaneous Lupus Erythematosus
Treatment
CLN-978
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of SLE at least 24 weeks prior to Screening and meet 2019 EULAR / ACRClassification Criteria at screening.
Presence of one or more of the following autoantibodies documented during screening:positive anti-nuclear antibody (ANA) test (≥1:80); anti dsDNA above the upper limitof normal (ULN); anti-Sm above the ULN.
Active SLE disease, as demonstrated by a SLEDAI total score ≥8 at screening.
Inadequate response to at least 2 of the following treatments: oral corticosteroid,antimalarials, conventional immunosuppressants, or biologics. At least one of thefailed 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 CD19+ 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) ≥30mL/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
Serum albumin >2.8 g/dL
Part B only: For patients who were treated in Part A and did not experiencedose-limiting toxicity (DLT) or discontinue CLN-978 treatment due to AEs areeligible for retreatment at a higher dose or longer schedule in Part B if theyotherwise meet eligibility criteria and at least 90 days have passed since the lastdose of CLN-978.
Exclusion
Exclusion Criteria:
Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren'ssyndrome is allowed.
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 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 or a biologic immunomodulating therapy during 2 months priorto 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 indeterminantInterferon Gamma Release Assay (IGRA), unless the patient has documented previouscompletion of TB treatment and no current clinical indication of TB.
Any condition for which, in the opinion of the Investigator and/or Sponsor, wouldnot be in the best interest of the patient to participate in the study or that couldprevent, limit, or confound any protocol-defined assessment.
Study Design
Connect with a study center
Cullinan Investigative Site
Victoria Park,
AustraliaActive - Recruiting
Arensia Research Clinic
Tbilisi,
GeorgiaActive - Recruiting
Arensia Research Clinic
Chisinau,
Moldova, Republic ofActive - Recruiting
IMSP Republican Clinical Hospital "Timofei Mosneaga"
Chisinau,
Moldova, Republic ofActive - Recruiting
Cullinan Investigative Site
Avondale, Arizona 85392
United StatesActive - Recruiting
Cullinan Investigative Site
Tucson, Arizona 85704
United StatesActive - Recruiting
Cullinan Investigative Site
Orlando, Florida 32808
United StatesActive - Recruiting
Omega Research Orlando, LLC
Orlando, Florida 32808
United StatesActive - Recruiting
Cullinan Investigative Site
Iowa City, Iowa 52242
United StatesActive - Recruiting
Cullinan Investigative Site
New York, New York 10032
United StatesActive - Recruiting
Cullinan Investigative Site
Rochester, New York 14642
United StatesActive - Recruiting
Cullinan Investigative Site
Plano, Texas 75093
United StatesActive - Recruiting
Cullinan Investigative Site
Webster, Texas 77598
United StatesActive - Recruiting
Tranquil Clinical Research
Webster, Texas 77598
United StatesActive - Recruiting
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