This Phase 1, open-label, dose-escalation and dose-expansion study evaluates the safety and clinical activity of UCART123v1.2, a universal CAR T cell product targeting CD123, in patients with relapsed or primary refractory acute myeloid leukemia (AML). The study also seeks to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Eligibility requires relapsed or refractory AML with at least 5% bone marrow blasts, CD123+ blast cells verified by flow cytometry, and an ECOG performance status of 1 or less.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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