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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
Description
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).
Trial 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
Study Info
Organization
Cellectis S.A.
Primary Outcome
Incidence of adverse events (AE)/serious adverse events (SAE)/Dose Limiting Toxicities (DLT) [Safety and Tolerability]
Interventions
Locations Recruiting
University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
United States, California, San Francisco
Sylvester Comprehensive Cancer Center
United States, Florida, Miami
H. Lee Moffitt Cancer Center & Research Institute
United States, Florida, Tampa
Northwestern University
United States, Illinois, Chicago
Dana-Farber Cancer Institute
United States, Massachusetts, Boston
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