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 Lupus Erythematosus

Description

This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic lupus erythematosus.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 engineered IL-2 beta receptor (hoRb); and (2) STK-009, an engineered pegylated IL-2 cytokine (hoIL-2) selective for hoRb. This study is being conducted to evaluate the safety and efficacy of a single dose of SYNCAR-001 followed by multiple subcutaneously administered doses of STK-009. No conditioning chemotherapy (lymphodepletion) will be administered. The study will follow a 3+3 design during dose escalation followed by dose expansion at the recommended phase 2 dose (RP2D).

Trial Eligibility

Inclusion Criteria: 1. Age ≥18 years at screening. 2. Clinical diagnosis of SLE according to the 2019 European League Rheumatism EULAR/ACR classification criteria. 3. 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). 4. Subjects with active, severe, non-renal SLE or subjects with active proliferative LN Exclusion Criteria: 1. History of or active central nervous system lupus. 2. Rapidly progressive glomerulonephritis. 3. 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. 4. Prior treatment with anti-CD19 adoptive T cell therapy, or any prior gene therapy product (e.g., CAR T cell therapy). Other protocol-defined criteria apply.

Study Info

Interventions

Locations Recruiting

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