TrialPath
Recruiting

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

NCT07041099 · Cullinan Therapeutics Inc.
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogren's Disease
About this study
A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.
Eligibility criteria
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)
Study design
Enrollment target: 36 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-01
Estimated completion: 2029-03-15
Last updated: 2026-08-11
Interventions
Drug: CLN-978
Primary outcomes
  • Safety and Tolerability (48 weeks)
Sponsor
Cullinan Therapeutics Inc. · industry
Contacts & investigators
ContactAmy Gubits, MPH · contact · ClinOps@cullinantx.com · +1 617 410 4650
All locations (14)
Omega ResearchRecruiting
Orlando, Florida, United States
New York UniversityRecruiting
Brooklyn, New York, United States
Regional OneRecruiting
Memphis, Tennessee, United States
Stryde ResearchRecruiting
Plano, Texas, United States
Tranquil ResearchRecruiting
Webster, Texas, United States
IntermountainRecruiting
Salt Lake City, Utah, United States
CHU BrestRecruiting
Brest, France
Hopitaux Universitaires Paris-SudRecruiting
Le Kremlin-Bicêtre, France
CHU NantesRecruiting
Nantes, France
CHU St.-ÉtienneRecruiting
Saint-Priest-en-Jarez, France
CHU Strasbourg-HautepierreRecruiting
Strasbourg, France
University Hospital ErlangenRecruiting
Erlangen, Germany
Hannover Medical SchoolRecruiting
Hanover, Germany
Fondazione Policlinico Universitario A GemelliRecruiting
Roma, Italy