A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease
Recruiting · NCT07041099 · Interventional (participants receive a specific treatment) · Lead sponsor: Cullinan Therapeutics Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Eligibility criteria (as published)
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)
Where it is running
14 locations listed across 5 US states.
- Omega Research - Orlando, Florida, United States
- New York University - Brooklyn, New York, United States
- Regional One - Memphis, Tennessee, United States
- Stryde Research - Plano, Texas, United States
- Tranquil Research - Webster, Texas, United States
- Intermountain - Salt Lake City, Utah, United States
- CHU Brest - Brest, France
- University Hospital Erlangen - Erlangen, Germany
- Hannover Medical School - Hanover, Germany
- Hopitaux Universitaires Paris-Sud - Le Kremlin-Bicêtre, France
- CHU Nantes - Nantes, France
- Fondazione Policlinico Universitario A Gemelli - Roma, Italy
- CHU St.-Étienne - Saint-Priest-en-Jarez, France
- CHU Strasbourg-Hautepierre - Strasbourg, France