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)

Cellectis S.A.

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)

Eligibility

Age range: 15–50 years
Sex: All
Healthy volunteers: No

Detailed criteria

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

Interventions

Biological
UCART22
Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen
Biological
CLLS52
A monoclonal antibody that recognizes a CD52 antigen

Locations (19)

University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California
University of Colorado - Aurora Cancer Center
Aurora, Colorado
Sarah Cannon - Colorado Blood Cancer Institute
Denver, Colorado
University of Chicago
Chicago, Illinois
Dana Farber Cancer Institute
Boston, Massachusetts
Roswell Park Comprehensive Cancer Center
Buffalo, New York