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

N/ATemporarily Not AvailableNCT07346105

Orca Biosystems, Inc.

Overview

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.

Study Type

EXPANDED_ACCESS

Conditions

Hematologic Malignancies Acute Myeloid Leukemia Acute Lymphoid Leukemia Myelodysplastic Syndrome Mixed Phenotype Acute Leukemia

Interventions

Orca-TBIOLOGICAL

Orca-T that does not meet commercial release specifications

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: Recipients in this EAP must meet all of the following criteria: 1. Commercial Orca-T was prescribed to the patient by their treating physician. 2. The final manufactured Orca-T does not meet the commercial release specifications or is delivered past expiry. 3. The final manufactured Orca-T is acceptable per joint assessment by Orca Bio and the treating physician, taking into account Orca Bio's release criteria. 4. Remanufacturing (ie, repeat leukapheresis and manufacturing) is not clinically appropriate per the treating physician's assessment. 5. Recipient must be deemed medically fit and stable to receive Orca-T infusions per the treating physician's evaluation. 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.

Data from ClinicalTrials.gov

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