NCT06544330View on ClinicalTrials.gov

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

PHASE1RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

April 29, 2025

Primary Completion Date

April 30, 2028

Study Completion Date

April 30, 2041

Conditions
Systemic Lupus ErythematosusLupus NephritisSystemic Sclerosis
Interventions
DRUG

SYNCAR-001

SYNCAR-001 is an autologous CD19-targeted CAR-T with co-expression of hoRb

DRUG

STK-009

STK-009 is a human orthogonal IL-2 cytokine selective for SYNCAR-001 CAR-T cells expressing hoRb

Trial Locations (5)

11030

RECRUITING

Feinstein Institutes for Medical Research, Manhasset

43210

RECRUITING

Ohio State University Wexner Medical Center, Columbus

44195

RECRUITING

The Cleveland Clinic Foundation, Cleveland

85258

RECRUITING

HonorHealth Research Institute, Scottsdale

07601

RECRUITING

Hackensack University Medical Center, Hackensack

Sponsors

Lead Sponsor

Synthekine
All Listed Sponsors
lead

Synthekine

INDUSTRY

NCT06544330 - A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease | Biotech Hunter | Biotech Hunter