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
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
- BiologicalUCART22
Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen
- BiologicalCLLS52
A monoclonal antibody that recognizes a CD52 antigen
Locations (19)
- University of California, Los Angeles (UCLA) - Medical CenterLos Angeles, California
- University of Colorado - Aurora Cancer CenterAurora, Colorado
- Sarah Cannon - Colorado Blood Cancer InstituteDenver, Colorado
- University of ChicagoChicago, Illinois
- Dana Farber Cancer InstituteBoston, Massachusetts
- Roswell Park Comprehensive Cancer CenterBuffalo, New York