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Clinical Trials in the USA / NCT06544330
Active, not recruiting Phase 1

A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease

NCT06544330 · tracked via the Priya Life Science USA tracker
Sponsor
Synthekine
Phase
Phase 1
Started
2025-04-29
Last updated
2026-07-10

Condition(s) studied

Systemic Lupus ErythematosusLupus NephritisSystemic Sclerosis

Investigational drug(s) / intervention(s)

SYNCAR-001STK-009

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)

Trial sites (6)

FacilityCityRegionStatus
HonorHealth Research Institute Scottsdale Arizona
Hackensack University Medical Center Hackensack New Jersey
Feinstein Institutes for Medical Research Manhasset New York
Columbia University Irving Medical Center New York New York
The Cleveland Clinic Foundation Cleveland Ohio
Ohio State University Wexner Medical Center Columbus Ohio

More Synthekine trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT06544330 on ClinicalTrials.gov ↗ ← All trials in the USA