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

Orca Bio

Status

Conditions: Mixed Phenotype Acute Leukemia; Acute Lymphoid Leukemia; Myelodysplastic Syndrome; Acute Myeloid Leukemia; Hematologic Malignancies

Treatments: Biological: Orca-T

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT07346105

Orca-T OOS EAP

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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.