Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07346105
Eligibility Criteria:
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.
Sex:
ALL
Study:
NCT07346105
Study Brief:
Protocol Section:
NCT07346105