Orca-T Expanded Access Program Study for Patients With Advanced Hematologic Malignancies
NCT07346105 · Status: TEMPORARILY_NOT_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2026-01-16
Summary
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.
Conditions
- Hematologic Malignancies
- Acute Myeloid Leukemia
- Acute Lymphoid Leukemia
- Myelodysplastic Syndrome
- Mixed Phenotype Acute Leukemia
Interventions
- BIOLOGICAL
-
Orca-T that does not meet commercial release specifications
Sponsors & Collaborators
-
Orca Biosystems, Inc.
lead INDUSTRY
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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