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)

Protocol # :
B-cell Acute Lymphoblastic Leukemia
Disease Sites
Lymphoid Leukemia
Principal Investigator
DeAngelo, Daniel, J

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