drugset / Trial / NCT04150497
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | UCART22 | Cell therapy | — | Intravenous |
| Background | Alemtuzumab | Monoclonal antibody | — | — |