RecruitingSLESLE (Systemic Lupus)
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
Eligible age
18–70 yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
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About this study
Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).
Sponsor: Cullinan Therapeutics Inc.
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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.
- ✕ Prior treatment with the following:
- ✕ Cellular or gene therapy product directed at any target.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06613360 · last updated 2026-06-05