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

Launched by SYNTHEKINE · Aug 6, 2024

Keywords

ClinConnect Summary

This clinical trial, called SYNCAR-001, is exploring a new treatment approach for people with severe systemic lupus erythematosus (SLE), a chronic autoimmune disease that can cause serious health issues. The study is testing a combination of two therapies: autologous CD19 CAR-T cell therapy and orthogonal IL-2. This treatment aims to better manage SLE, especially for patients who have not responded well to other treatments.

To be eligible for the trial, participants must be at least 18 years old and have a confirmed diagnosis of systemic lupus erythematosus according to specific medical guidelines. They should also show signs of active disease, either with severe symptoms affecting areas outside the kidneys or with a particular type of kidney inflammation known as proliferative lupus nephritis. Participants can expect to receive the new treatment and will be monitored closely for any effects. This trial is currently recruiting participants, and it's an opportunity for those struggling with severe lupus to potentially benefit from an innovative therapy.

Gender

ALL

Eligibility criteria

• 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.