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

Status: Recruiting
Location: See all (3) locations...
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
Utah
Cullinan Investigative Site
RECRUITING
Salt Lake City
Other Locations
Germany
Cullinan Investigative Site
RECRUITING
Erlangen
Contact Information
Primary
Amy Gubits, MPH
ClinOps@cullinantx.com
+1 617 410 4650
Time Frame
Start Date: 2025-10-01
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