A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogren's Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
Cullinan Investigative Site
RECRUITING
Plano
Contact Information
Primary
Amy Gubits, MPH
ClinOps@cullinantx.com
+1 617 410 4650
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2029-03-15
Participants
Target number of participants: 36
Treatments
Experimental: Part A Dose Escalation
Patients with Sjogren's Disease treated with CLN-978 in dose escalation cohorts
Experimental: Part B Further Dose Evaluation
Further evaluation of CLN-978 treatment of patients with Sjogren's Disease
Sponsors
Leads: Cullinan Therapeutics Inc.

This content was sourced from clinicaltrials.gov