A Phase I, open-label study of CLN-978 in patients with treatment-refractory rheumatoid arthritis.
Documented diagnosis of RA which fulfills the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria ≥12 weeks prior to screening.
Evidence of B-cell-driven disease at Screening or previous medical documentation, defined as either (i) seropositivity for RF and/or any AMPA and/or (ii) a synovial biopsy showing B-cell infiltration
Active RA disease, as demonstrated by a DAS28 - ESR ≥3.2 and at least one swollen joint at screening.
Inadequate response to at least 2 targeted treatments with different mechanisms. These can include tsDMARD and/or bDMARD, after failing conventional synthetic DMARD (unless contraindicated).
Active inflammatory disease other than RA within 12 months prior to screening or during screening that may interfere with the study assessments. Thyroiditis or secondary Sjogren's syndrome is allowed.
Clinical evidence of any other significant unstable or uncontrolled acute or chronic disease not due to RA which, in the opinion of the Investigator could put the patient at undue risk or confound study results.
Cellular therapy (e.g., chimeric antigen receptor T-cell (CAR-T) or gene therapy product directed at any target.
Receipt of an investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1 and during the study.
Sequential
CLN-978
DrugSpecified dose on specified days
Incidence and severity of adverse events
Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs)
Serum concentrations of CLN-978
Serum concentrations of CLN-978
Level of anti-drug antibodies
Level of anti-drug antibodies
Pharmacodynamics-related biomarker
Levels of total B lymphocytes in the peripheral blood
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