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Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Sponsor: 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)
Official 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 refractoryCD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)
Key Details
Gender
All
Age Range
15 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2019-10-14
Completion Date
2026-06-30
Last Updated
2025-09-09
Healthy Volunteers
No
Conditions
Interventions
UCART22
Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen
CLLS52
A monoclonal antibody that recognizes a CD52 antigen
Locations (19)
University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California, United States
University of Colorado - Aurora Cancer Center
Aurora, Colorado, United States
Sarah Cannon - Colorado Blood Cancer Institute
Denver, Colorado, United States
University of Chicago
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Sarah Cannon - HCA Research Institute
Nashville, Tennessee, United States
Sarah Cannon - St. David's South Austin Medical Center
Austin, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Sarah Cannon - Texas Transplant Institute at Methodist Hospital
San Antonio, Texas, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
CHU de Nantes - Hôtel-Dieu
Nantes, France
Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hématologie
Paris, France
Hôpital Robert Debré - Service d'hémato-immunologie
Paris, France
Hôpital Lyon Sud
Pierre-Bénite, France
CHU Rennes - Hopital Pontchaillou
Rennes, France