Title
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)

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)

Objective
Primary Objectives:

Phase 1
Dose escalation
- To assess the safety and tolerability ofUCART22 administered to subjects with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL)
-To determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of UCART22 in subjects with R/R B-ALL

Sub-study FCA (mg/kg alemtuzumab dose)
- To assess the safety and tolerability of UCART22 following FCA with weight-based dosing of alemtuzumab in subjects with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL)

Phase 2- Dose Expansion
- To confirm the MTD and/or RP2D in subjects with R/R B-ALL who have failed a CD19-directed therapy

Treatment 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 refractoryCD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)

Key Eligibility 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 90 days prior to enrollment

Applicable Disease Sites
Leukemia

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital