drugset / Trial / NCT04150497

Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)

NCT04150497

Phase 1/2 Recruiting 52 enrolled Cellectis S.A.
NaSingle-groupOpen-labelTreatment

Summary

This is a first-in-human, open-label, dose escalation and expansion study of UCART22 administered intravenously to patients with relapsed or refractory B-cell acute Lymphoblastic Leukemia (B-ALL). The purpose of this study is to evaluate the safety and clinical activity of UCART22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

Timeline

Start
2019-10-14
Primary completion
2026-06-30
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject UCART22 Cell therapy Intravenous
Background Alemtuzumab Monoclonal antibody