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.
You may not be if
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.
