A Phase 1, Open-Label Study to Evaluate the Safety and Tolerability of a Combination Autologous CD19 CAR T Cell Therapy (SYNCAR-001 + STK-009) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ Age ≥18 years at screening.
⁃ SLE Inclusion Criteria:
• Clinical diagnosis of SLE according to the 2019 European League Rheumatism EULAR/ACR classification criteria.
• Subject must be positive for at least one of the following at screening: Anti-dsDNA (above the upper limit of normal \[ULN\]); or anti-Sm (above the ULN); or anti-Chromatin (above the ULN).
• Subjects with active, severe, non-renal SLE or subjects with active proliferative LN
⁃ SSc Inclusion Criteria:
• Classified as SSc according to the ACR/EULAR classification criteria.
• Diffuse cutaneous SSc (dcSSc) or SSc-associated ILD (SSc-ILD; significant or progressive).
Locations
United States
Arizona
HonorHealth Research Institute
RECRUITING
Scottsdale
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
New York
Feinstein Institutes for Medical Research
RECRUITING
Manhasset
Ohio
The Cleveland Clinic Foundation
RECRUITING
Cleveland
Ohio State University Wexner Medical Center
RECRUITING
Columbus
Contact Information
Primary
Clinical Operations
clinicaltrialinfo@synthekine.com
650.271.9888
Time Frame
Start Date:2025-04-29
Estimated Completion Date:2041-04
Participants
Target number of participants:48
Treatments
Experimental: SYNCAR-001 + STK-009
Dose escalation: A single fixed dose of autologous SYNCAR-001 CAR-T intravenously (IV) will be administered in combination with ascending doses of STK-009 subcutaneously (SC) in non-lymphodepleted patients.~Dose expansion: A single fixed dose of autologous SYNCAR-001 CAR-T IV will be administered in combination with STK-009 SC at the RP2D in non-lymphodepleted patients.