AML-521 Treatment of Acute Myeloid Leukemia With Orca-T

• Published in: Clinical lymphoma, myeloma and leukemia myeloma and leukemia, 2024-09, Vol.24, p.S317-S317
• Main Authors: Srour, Samer, Pantin, Jeremy, Patel, Sagar, Faramand, Rawan, Gandhi, Arpita, Salhotra, Amandeep, Oliai, Caspian, Dholaria, Bhagirathbhai, Pavlova, Anna, McClellan, Scott, Agodoa, Irene, Li, Ai, Fernhoff, Nathaniel, Abedi, Mehrdad, Meyer, Everett
• Format: Article
• Language: English
• Subjects: alloHSCT; AML; Orca-T; overall survival; relapse-free survival
• ISSN: 2152-2650
• DOI: 10.1016/S2152-2650(24)01207-2

Allogeneic hematopoietic stem cell transplant (alloHSCT) offers a potential curative treatment for many hematological cancers; however, traditional alloHSCT is associated with high mortality from complications including infection, graftversus-host disease (GvHD) and relapse. Orca-T is an investigational allogeneic T-cell immunotherapy that includes stem and immune cells, and leverages highly purified, polyclonal donor regulatory T cells to control alloreactive immune responses. In this sub-group analysis, we evaluated the safety and efficacy of patients with acute myeloid leukemia (AML) who were treated with Orca-T. Data from 37 patients with diagnosis of AML in CR/CRi who received myeloablative conditioning with busulfan, fludarabine, and thiotepa (BFT) followed by Orca-T as of 6/30/22 as part of a multicenter phase 1b single-arm trial (NCT04013685), are reported here. Patients received single-agent GvHD prophylaxis with tacrolimus, and had an 8/8 related or unrelated matched donor. Orca-T was successfully manufactured at a centralized GMP facility, distributed, and infused at study sites throughout the U.S. Vein-to-vein time was