Active — Not RecruitingPhase 1

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

United States48 participantsStarted 2025-04-29

Plain-language summary

This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. Classified as SSc according to the ACR/EULAR classification criteria.
✓. Diffuse cutaneous SSc (dcSSc) or SSc-associated ILD (SSc-ILD; significant or progressive).

✕. 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).
✕. 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.
✕. FVC \<50% of predicted or DLCO \<40% of predicted.
✕. Pulmonary arterial hypertension (PAH) requiring PAH-specific treatment.

Dose-Limiting Toxicities (DLTs)

Timeframe: Up to 28 days after SYNCAR-001 infusion

Adverse Events

Timeframe: Up to 96 weeks after SYNCAR-001 infusion

NCT IDNCT06544330

SponsorSynthekine

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. Classified as SSc according to the ACR/EULAR classification criteria.
✓. Diffuse cutaneous SSc (dcSSc) or SSc-associated ILD (SSc-ILD; significant or progressive).

✕. 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).
✕. 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.
✕. FVC \<50% of predicted or DLCO \<40% of predicted.
✕. Pulmonary arterial hypertension (PAH) requiring PAH-specific treatment.