Status:
ACTIVE_NOT_RECRUITING
A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease
Lead Sponsor:
Synthekine
Conditions:
Systemic Lupus Erythematosus
Lupus Nephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.
Detailed Description
SYNCAR-001 + STK-009 is a 2-component human orthogonal (ho) IL-2 receptor-ligand cell therapy consisting of (1) SYNCAR-001, a CD19-directed chimeric antigen receptor T cell (CAR-T) co-expressing an en...
Eligibility Criteria
Inclusion
- General
- Age ≥18 years at screening.
- SLE
- 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
- Classified as SSc according to the ACR/EULAR classification criteria.
- Diffuse cutaneous SSc (dcSSc) or SSc-associated ILD (SSc-ILD; significant or progressive).
- General
Exclusion
- History of or active central nervous system manifestations of autoimmune disease.
- Prior treatment with anti-CD19 adoptive T cell therapy, or any prior gene therapy product (e.g., CAR T cell therapy).
- SLE
Key Trial Info
Start Date :
April 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2041
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06544330
Start Date
April 29 2025
End Date
April 1 2041
Last Update
November 4 2025
Active Locations (5)
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1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
2
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
3
Feinstein Institutes for Medical Research
Manhasset, New York, United States, 11030
4
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195