Actively Recruiting
A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogren's Disease
Led by Cullinan Therapeutics Inc. · Updated on 2026-03-23
36
Participants Needed
11
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CLN-978, a subcutaneously administered CD19-directed T cell engager, in patients with active, moderate to severe Sjogren's Disease. This phase 1b, open-label study aims to assess the safety and tolerability of CLN-978 as well as its effects on B lymphocyte levels in peripheral blood over a 48-week period. Participants will receive CLN-978 in dose escalation cohorts during the initial phase, followed by further evaluation of the treatment. The drug is administered at specified doses on specified days, with no placebo group. The study consists of two parts: Part A for dose escalation and Part B for further dose evaluation. Throughout the 48 weeks of the study, participants will undergo safety monitoring, pharmacokinetic assessments, and tests for anti-drug antibodies. Blood tests will measure changes in lymphocyte counts and B cell numbers. The study involves regular visits for these evaluations and monitoring of tolerability and immune response.
CONDITIONS
Brief 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 the screening visit
- Meet the 2016 EULAR / ACR Classification Criteria for Sjogren's Disease at screening
- Active moderate to severe disease with ESSDAI score of 5 or higher at screening
- Absolute lymphocyte count (ALC) of 0.5 x 10^9/L or higher
- Peripheral CD19+ B cell count of 25 cells/µL or higher
- Absolute neutrophil count (ANC) of 1.0 x 10^9/L or higher
- Hemoglobin (Hgb) of 8 g/dL or higher
- Platelet count of 75 x 10^9/L or higher
- Total bilirubin 1.5 times the upper limit of normal or less (except for confirmed Gilbert's Syndrome)
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) up to 2 times the upper limit of normal
- Estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m2 or higher based on CKD-EPI formula
You will not qualify if you...
- Having another rheumatological autoimmune disease alongside Sjogren's Disease
- Being at high risk for blood clots (thrombosis)
- Rapidly progressive glomerulonephritis or urine protein/creatinine ratio over 3 mg/mg (339 mg/mmol)
- Active, severe central nervous system symptoms related to Sjogren's Disease
- History of stroke, seizure, dementia, Parkinson's disease, coordination or cerebellar disorders, psychosis, paresis, aphasia, or other neurologic disorders posing undue risk
- Evidence of infections with hepatitis B, hepatitis C, HIV, Epstein-Barr virus, or cytomegalovirus
- Primary immunodeficiency or history of repeated infections
- Having had a splenectomy
- Receiving live or attenuated vaccine within 28 days before screening or during screening period
- Active significant infections, including COVID-19, within 14 days before day 1
- Active or latent tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive subcutaneous administration of CLN-978, a CD19-directed T cell engager, to treat active moderate to severe Sjogren's Disease.
Weekly visits for up to 48 weeks
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here