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Study Evaluating Safety and Efficacy of UCART123v1.2 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Sponsor: Cellectis S.A.
Summary
Phase I, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of Universal Chimeric Antigen Receptor T-cell (UCART) targeting the Cluster of Differentiation 123 (CD123) in patients with relapsed/refractory acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety and clinical activity of Universal Chimeric Antigen Receptor T-cells targeting CD123 (UCART123v1.2) and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).
Official title: Phase I, Open Label Dose Escalation and Dose-Expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of UCART123 (Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor), Administered in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
29
Start Date
2017-06-19
Completion Date
2025-12
Last Updated
2025-08-07
Healthy Volunteers
No
Interventions
UCART123v1.2
Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor Biological/vaccine: CLLS52 A monoclonal antibody that recognizes the CD52 antigen Other Names: Alemtuzumab
Locations (8)
University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States