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)
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)
Arms & 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
Outcome measures
Primary
Incidence of AE/SAE/DLT [Safety and Tolerability]
Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study in relation to UCART22 and/or lymphodepletion
Time frame: 24 Months
Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)
Time frame: Up to D28 post initial UCART22 infusion
Secondary
Investigator assessed overall response rate according to the Response criteria for Acute Lymphoblastic Leukemia (ALL)
Time frame: At Day 28, Day 56, Day 84, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and Month 24
Duration of Response
Time frame: From the date of the initial response to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24
Progression Free Survival
Time frame: From the first day of study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24
Overall Survival
Time frame: From the first day of study treatment to the date of death from any cause, assessed up to Month 24
Pharmacokinetic (PK) profile/exposure levels of CLLS52 (Alemtuzumab) used during lymphodepletion
Time frame: Lymphodepletion to Day 56
Eligibility criteria
Study locations (14)
University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California, 90095
University of Colorado - Aurora Cancer Center
Aurora, Colorado, 80045
Sarah Cannon - Colorado Blood Cancer Institute
Denver, Colorado, 80218
University of Chicago
Chicago, Illinois, 60647
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Weill Medical College of Cornell University
New York, New York, 10065
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Sarah Cannon - HCA Research Institute
Nashville, Tennessee, 37203
Sarah Cannon - St. David's South Austin Medical Center
Austin, Texas, 78704
MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon - Texas Transplant Institute at Methodist Hospital
San Antonio, Texas, 78229
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792