Phase I, open label dose-escalation and dose-expansion study to evaluate the safety, expansion, persistence and clinical activity of UCART22 (allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor) in patients with relapsed or refractory CD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)
Trial Description
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)
Eligibility Requirements
Inclusion Criteria:
- B-ALL blast cells expressing CD22
- Diagnosed with R/R B-ALL
- Prior therapy must include at least one standard chemotherapy regimen and at least one
salvage regimen
Exclusion Criteria:
-Prior cellular therapy or investigational cellular or gene therapy within 60 days prior to
enrollment