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Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies
Sponsor: Synthekine
Summary
This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+ hematologic malignancies.
Official title: A Phase 1 Study to Evaluate the Safety and Tolerability of a Combination Autologous CD19 CAR T Cell Therapy (SYNCAR-001 + STK-009) in Subjects With Relapsed or Refractory CD19+ Hematologic Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2023-04-23
Completion Date
2026-11
Last Updated
2025-04-06
Healthy Volunteers
No
Conditions
Interventions
SYNCAR-001
SYNCAR-001 is an autologous CD19-targeted CAR-T with co-expression of hoRb
STK-009
STK-009 is a human orthogonal IL-2 cytokine selective for SYNCAR-001 CAR-T cells expressing hoRb
Cyclophosphamide
lymphodepletion
Fludarabine
lymphodepletion
Locations (4)
City of Hope
Duarte, California, United States
Roswell Park
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States