Orca-T Expanded Access Program Study for Patients With Advanced Hematologic Malignancies

Summary

This study is not designed to test a hypothesis; rather, this study will provide patients with access to Orca-T if the commercial Orca-T product produced for them is deemed out of specification (OOS). Serious adverse events (SAEs) occurring during the safety reporting period (defined as the day the recipient receives the Orca-T HSPC drug product through day +365 after transplantation or until initiation of new anticancer therapy, whichever occurs sooner) will be reported.

Timeline

Start

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Primary completion

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Completion

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Publications

• Background Meyer EH, Salhotra A, Gandhi AP, Pantin J, Patel SS, Hoeg RT, Gomez-Arteaga A, Faramand R, Tamari R, Waller EK, Kosuri S, Jimenez Jimenez AM, Holter-Chakrabarty J, Dholaria B, Chen YB, Hamilton BK, Magenau J, Eghtedar A, Murray JM, Pavlova A, Fernhoff NB, McClellan JS, Killian MS, Li A, Negrin RS, Oliai C. Orca-T vs allogeneic hematopoietic stem cell transplantation (Precision-T): a multicenter, randomized phase 3 trial. Blood. 2026 Mar 12;147(11):1168-1177. doi: 10.1182/blood.2025031313.

Drugs

Indications