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
Conditions
SjögrenSjogren DiseaseSjogren's Syndrome
Locations
Cullinan Investigative Site
Orlando, Florida 32808
United States
Cullinan Investigative Site
Memphis, Tennessee 38103
United States
Cullinan Investigative Site
Plano, Texas 75093
United States
Cullinan Investigative Site
Webster, Texas 77598
United States
Cullinan Investigative Site
Salt Lake City, Utah 84107
United States
Cullinan Investigative Site
Brest, 29609
France
Cullinan Investigative Site
Le Kremlin-Bicêtre, 94270
France
Cullinan Investigative Site
Strasbourg, 67098
France
Cullinan Investigative Site
Erlangen, 91054
Germany
Cullinan Investigative Site
Hanover, 30625
Germany
Cullinan Investigative Site
Roma, 00168
Italy