NCT06613360
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
Recruiting · Phase 1 · Cullinan Therapeutics Inc. · registry updated 2026-06-05
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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:
Exclusion
- Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren's syndrome 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.