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

NCT05114837 Phase 1/Phase 2 WITHDRAWN

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.

Details

Lead sponsor	Masonic Cancer Center, University of Minnesota
Phase	Phase 1/Phase 2
Status	WITHDRAWN
Start date	2024-09
Completion	2028-08

Conditions

• Lymphoma Leukemia

Interventions

• allogeneic CAR19 regulatory T cells (CAR19-tTreg)
• Fludarabine
• Cyclophosphamide

Primary outcomes

• Dose Finding of CAR19-tTregs — 28 days after CAR19-tTregs administrations
  To identify the MTD of CAR19-tTregs defined asthe dose level that most closely corresponds to a dose limiting toxicity rate(DLT) less than or equal to 25%. Using grade 3-5 Common Terminology Criteria for Adverse Events version 5 (CTCAEv5) Statistical Analysis: The proportion of patients with ORR, CR and adverse events by day 28 will be estimated by simple proportions with 95% confidence intervals
• Measure CAR19-tTregs efficacy — 28 days after CAR19-tTregs administrations
  Efficacy estimate as measured by overall response rate

Countries

United States