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

Criteria the registry did not label

• General Inclusion Criteria:
• Age ≥18 years at screening.
• SLE Inclusion Criteria:
• 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 Inclusion Criteria:
• 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 Criteria:
• 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 Exclusion Criteria:
• Rapidly progressive glomerulonephritis.
• 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:
• FVC \<50% of predicted or DLCO \<40% of predicted.
• Pulmonary arterial hypertension (PAH) requiring PAH-specific treatment.
  • Other protocol-defined criteria apply.