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NCT07041099PHASE1Recruiting

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

Cullinan Therapeutics Inc.

Start Date

10/1/2025

Completion Date

3/15/2029

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

DRUG

CLN-978

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Conditions

SjögrenSjogren DiseaseSjogren's Syndrome

Locations

Omega Research

Orlando, Florida 32808

United States

New York University

Brooklyn, New York 11201

United States

Regional One

Memphis, Tennessee 38103

United States

Stryde Research

Plano, Texas 75093

United States

Tranquil Research

Webster, Texas 77598

United States

Intermountain

Salt Lake City, Utah 84143

United States

CHU Brest

Brest, 29609

France

Hopitaux Universitaires Paris-Sud

Le Kremlin-Bicêtre, 94270

France

CHU Nantes

Nantes, 44093

France

CHU St.-Étienne

Saint-Priest-en-Jarez, 42270

France

CHU Strasbourg-Hautepierre

Strasbourg, 67098

France

University Hospital Erlangen

Erlangen, 91054

Germany

Hannover Medical School

Hanover, 30625

Germany

Fondazione Policlinico Universitario A Gemelli

Roma, 00168

Italy