Actively Recruiting
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease
Led by Cullinan Therapeutics Inc. · Updated on 2026-03-23
36
Participants Needed
11
Research Sites
180 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Sjogren's Disease at least 24 weeks before screening and meeting 2016 EULAR/ACR criteria at screening
- Active moderate to severe disease with ESSDAI score 5 or higher at screening
- Absolute lymphocyte count of at least 0.5 x 10^9/L
- Peripheral CD19+ B cell count of at least 25 cells/µL
- Absolute neutrophil count of at least 1.0 x 10^9/L
- Hemoglobin level of at least 8 g/dL
- Platelet count of at least 75 x 10^9/L
- Total bilirubin less than or equal to 1.5 times the upper limit of normal, except in patients with confirmed Gilbert's Syndrome
- AST and ALT less than or equal to 2.0 times the upper limit of normal
- Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2 based on the CKD-EPI formula
You will not qualify if you...
- Presence of another rheumatological autoimmune disease
- High risk for thrombosis
- Rapidly progressive glomerulonephritis or urine protein/creatinine ratio greater than 3 mg/mg (339 mg/mmol)
- Active severe central nervous system symptoms of Sjogren's Disease
- History of various neurological disorders including stroke, seizure, dementia, Parkinson's disease, coordination disorders, psychosis, paresis, aphasia, or other neurologic conditions posing undue risk
- Evidence of infection with hepatitis B, hepatitis C, HIV, Epstein-Barr virus, or cytomegalovirus
- Primary immunodeficiency or history of recurrent infections
- History of splenectomy
- Receipt of live or attenuated vaccine within 28 days before screening or during screening
- Active significant infections including bacterial, viral, fungal, mycobacterial, parasitic infections or COVID-19 within 14 days prior to Day 1
- Active or latent tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Cullinan Investigative Site
Orlando, Florida, United States, 32808
Actively Recruiting
2
Cullinan Investigative Site
Memphis, Tennessee, United States, 38103
Actively Recruiting
3
Cullinan Investigative Site
Plano, Texas, United States, 75093
Actively Recruiting
4
Cullinan Investigative Site
Webster, Texas, United States, 77598
Actively Recruiting
5
Cullinan Investigative Site
Salt Lake City, Utah, United States, 84107
Actively Recruiting
6
Cullinan Investigative Site
Brest, France, 29609
Actively Recruiting
7
Cullinan Investigative Site
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
8
Cullinan Investigative Site
Strasbourg, France, 67098
Actively Recruiting
9
Cullinan Investigative Site
Erlangen, Germany, 91054
Actively Recruiting
10
Cullinan Investigative Site
Hanover, Germany, 30625
Actively Recruiting
11
Cullinan Investigative Site
Roma, Italy, 00168
Actively Recruiting
Research Team
A
Amy Gubits, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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