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NCT06544330 | RECRUITING | Systemic Lupus Erythematosus

Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With Severe, Refractory Systemic Lupus Erythematosus
Sponsor:

Synthekine

Brief Summary:

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

Condition or disease

Systemic Lupus Erythematosus

Lupus Nephritis

Intervention/treatment

SYNCAR-001

STK-009

Phase

PHASE1

Detailed Description:

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 42 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-03
Estimated Primary Completion Date : 2028-04
Estimated Study Completion Date : 2041-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With Severe, Refractory Systemic Lupus Erythematosus

Location Details

NCT06544330

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

HonorHealth Research Institute

Scottsdale, Arizona, United States, 85258

RECRUITING

United States, New York

Feinstein Institutes for Medical Research

Manhasset, New York, United States, 11030

RECRUITING

United States, Ohio

The Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195