A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease
SYNCAR-001: SYNCAR-001 is an autologous CD19-targeted CAR-T with co-expression of hoRb
STK-009: STK-009 is a human orthogonal IL-2 cytokine selective for SYNCAR-001 CAR-T cells expressing hoRb
Study summary
This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
General Inclusion Criteria:
Age ≥18 years at screening.
SLE Inclusion Criteria:
1. Clinical diagnosis of SLE according to the 2019 European League Rheumatism EULAR/ACR classification criteria.
2. 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).
3. Subjects with active, severe, non-renal SLE or subjects with active proliferative LN
SSc Inclusion Criteria:
1. Classified as SSc according to the ACR/EULAR classification criteria.
2. Diffuse cutaneous SSc (dcSSc) or SSc-associated ILD (SSc-ILD; significant or progressive).
General Exclusion Criteria:
1. History of or active central nervous system manifestations of autoimmune disease.
2. Prior treatment with anti-CD19 adoptive T cell therapy, or any prior gene therapy product (e.g., CAR T cell therapy).
SLE Exclusion Criteria:
1. Rapidly progressive glomerulonephritis.
2. End stage renal failure requiring dialysis or most recent renal biopsy with purely chronic lesions (Class III\[C\], IV-S\[C\], or IV-G\[C\]) if isolated renal disease.
SSc Exclusion Criteria:
1. FVC \<50% of predicted or DLCO \<40% of predicted.
2. Pulmonary arterial hypertension (PAH) requiring PAH-specific treatment.
Other protocol-defined criteria apply.
Primary outcome measure(s)
Dose-Limiting Toxicities (DLTs) — Up to 28 days after SYNCAR-001 infusion Incidence of adverse events (AEs) meeting protocol defined DLT criteria in the dose escalation phase of the study.
Adverse Events — Up to 96 weeks after SYNCAR-001 infusion Incidence and severity of AEs including treatment-emergent AEs and serious AEs.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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