Acute Myeloid Leukemia Clinical Trial
Study Evaluating Safety and Efficacy of UCART123v1.2 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Summary
Phase I, first-in-human, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of UCART targeting CD123 in patients with relapsed/refractory acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety and clinical activity of UCART123v1.2 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).
Eligibility Criteria
Main Inclusion Criteria:
Patients with relapsed or primary refractory AML (as defined in World Health Organization [WHO] criteria) with ≥5% bone marrow blasts
Patients with CD123+ blast cells (verified by flow cytometry)
Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of ≤1
Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within screening period
(Dose-escalation) Identified donor and transplant strategy prior to lymphodepletion (LD)
Other criteria may apply
Main Exclusion Criteria:
Patients with acute promyelocytic leukemia (APL) or central nervous system (CNS) Leukemia
Previous investigation gene or cell therapy (including CAR)
> 1 prior allogeneic stem cell transplantations (SCTs)
Prior treatment with rituximab or other anti-cluster of differentiation 20 (anti-CD20) therapy within 3 months
Any known active or uncontrolled infection
Other criteria may apply
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There are 9 Locations for this study
San Francisco California, 94143, United States
Miami Florida, 33136, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60201, United States
Boston Massachusetts, 02215, United States
Buffalo New York, 14263, United States
New York New York, 10021, United States
Philadelphia Pennsylvania, 19104, United States
Houston Texas, 77030, United States
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