Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

April 23, 2023

Primary Completion Date

June 24, 2026

Study Completion Date

November 30, 2026

Conditions
CLL/SLLNHLMantle Cell LymphomaFollicular LymphomaLarge B-cell LymphomaIndolent B-Cell Non-Hodgkin LymphomaDiffuse Large B Cell Lymphoma
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

DRUG

Cyclophosphamide

lymphodepletion

DRUG

Fludarabine

lymphodepletion

Trial Locations (4)

10065

Memorial Sloan Kettering Cancer Center, New York

14263

Roswell Park, Buffalo

44195

Cleveland Clinic, Cleveland

91010

City of Hope, Duarte

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Synthekine

INDUSTRY

NCT05665062 - Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies | Biotech Hunter | Biotech Hunter