drugset / Trial / NCT05665062

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

NCT05665062 ↗

Phase 1 Active not recruiting 36 enrolled Synthekine
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+ hematologic malignancies.

Timeline

Start
2023-04-23
Primary completion
2028-06-24
Completion
2041-11

Drugs

EvaluationDrugModalityDoseRoute
Subject STK-009 Protein / enzyme biologic — Subcutaneous
Subject SYNCAR-001 Cell therapy — Intravenous
Background Cyclophosphamide Other / unclassified — —
Background Fludarabine Small molecule — —