drugset
drugset / Trial / NCT05702853

Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory NHL, CLL/SLL

NCT05702853 ↗

Phase 1/2 Recruiting 27 enrolled Medical University of South Carolina
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a single-center, nonrandomized, open-label dose-escalation study followed by dose-expansion of CD19- CD34t metabolically programmed CAR T-cell therapy in adult patients with relapsed or refractory CD19 B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Timeline

Start
2023-11-06
Primary completion
2026-11-06
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject CD19-CD34t metabolically programmed CAR transduced T-cells Cell therapy 1 cells/kg Intravenous
Subject CD19-CD34t metabolically programmed CAR transduced T-cells Cell therapy 1.5 cells/kg Intravenous
Subject CD19-CD34t metabolically programmed CAR transduced T-cells Cell therapy 2 cells/kg Intravenous
Background Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous

Indications

B-cell chronic lymphocytic leukemia