Ireland
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Recruiting Phase 1

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease

NCT07041099 · tracked via the Priya Life Science Italy tracker
Phase
Phase 1
Started
2025-10-01
Last updated
2026-08-11

Condition(s) studied

SjögrenSjogren DiseaseSjogren's Syndrome

Investigational drug(s) / intervention(s)

CLN-978 →

CLN-978: Specified dose on specified days

Study summary

A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion * Diagnosis of SjD at least 24 weeks prior to Screening Visit and meet the 2016 EULAR / ACR Classification Criteria for SjD at Screening. * Have active moderate to severe disease (i.e., ESSDAI ≥5) at Screening. * Laboratory parameters including the following: * Absolute lymphocyte count (ALC) ≥0.5 × 10\^9/L * Peripheral CD19+ B cell count ≥25 cells/µL * Absolute neutrophil count (ANC) ≥1.0 × 10\^9/L * Hemoglobin (Hgb) ≥8 g/dL * Platelet count ≥75 × 10\^9/L * Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 × ULN * Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥30 mL/min/1.73 m2 Exclusion * Concomitant rheumatological autoimmune disease * Considered at high risk for thrombosis * Rapidly progressive glomerulonephritis and/or urine protein/creatinine \>3 mg/mg (339 mg/mmol). * Active, severe central nervous system manifestations of SjD. * History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder that the Investigator feels would put the patient at undue risk or confound study results. * Evidence of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection. * Primary immunodeficiency or history of recurrent infections. * History of splenectomy. * Live or attenuated vaccine within 28 days prior to the Screening Visit or during the Screening Period. * Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, within 14 days prior to Day 1. * Active or latent tuberculosis (TB)

Primary outcome measure(s)

  • Safety and Tolerability — 48 weeks
    Incidence and severity of adverse events (AEs), serious AEs (SAEs), AEs of special interest (AESIs).

Trial sites (14)

FacilityCityRegionStatus
Omega Research Orlando Florida Recruiting
New York University Brooklyn New York Recruiting
Regional One Memphis Tennessee Recruiting
Stryde Research Plano Texas Recruiting
Tranquil Research Webster Texas Recruiting
Intermountain Salt Lake City Utah Recruiting
CHU Brest Brest France Recruiting
Hopitaux Universitaires Paris-Sud Le Kremlin-Bicêtre France Recruiting
CHU Nantes Nantes France Recruiting
CHU St.-Étienne Saint-Priest-en-Jarez France Recruiting
CHU Strasbourg-Hautepierre Strasbourg France Recruiting
University Hospital Erlangen Erlangen Germany Recruiting
Hannover Medical School Hanover Germany Recruiting
Fondazione Policlinico Universitario A Gemelli Roma Italy Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07041099 on ClinicalTrials.gov ↗ ← All trials in Italy