NCT05114837

Ph I/II Study of CAR19 Regulatory T Cells (CAR19-tTreg) for R/R CD19+ B-ALL

Phase I/II First-in-Human Trial With CAR19 Regulatory T Cells (CAR19-tTreg) in Adults With Relapsed/Refractory CD19+ B Acute Lymphocytic Leukemia

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, single-arm, interventional phase I/II trial to evaluate the safety profile and potential efficacy of allogeneic CAR19 regulatory T cells (CAR19-tTreg) in adults with relapsed/refractory (R/R) CD19+ B Acute Lymphocytic Leukemia (B-ALL). The study consists of two components. The dose finding component is a modified version of a Phase I trial and the extended component is a modified Phase II trial.

Conditions

• Lymphoma Leukemia

Interventions

Type	Name	Description
DRUG	allogeneic CAR19 regulatory T cells (CAR19-tTreg)	A single dose administration of CAR19-tTreg
DRUG	Fludarabine	Fludarabine 30 mg/m\^2 is administered as an intravenous (IV) infusion per institutional guidelines once a day on 4 consecutive days (Day -5, Day -4, Day -3 and Day -2)
DRUG	Cyclophosphamide	Cyclophosphamide 500 mg/m\^2 is administered as an IV infusion per institutional guidelines once a day on 2 consecutive days (Day -5, and Day -4)

Timeline

• Start date: 2024-09-01
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2021-11-10
• Last updated: 2024-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study