An expanded access record providing Orca-T in Hematologic Malignancies, Acute Myeloid Leukemia and Acute Lymphoid Leukemia, sponsored by Orca Biosystems, Inc.. Available at 8 sites in United States. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Orca Biosystems, Inc. · Expanded access
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.
Recipients in this EAP must meet all of the following criteria:
Exclusion Criteria:
Recipients with any medical condition identified by the treating physician that may impact the safety or outcomes of the recipient in relation to treatment with Orca-T will not be eligible.
Orca-T that does not meet commercial release specifications
Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.
Contact the providerGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Orca Biosystems, Inc.