Trials / Temporarily Not Available
Temporarily Not AvailableNCT07346105
Orca-T Expanded Access Program Study for Patients With Advanced Hematologic Malignancies
An Expanded Access Program for Orca-T Products That Are Out of Specification for Commercial Release
- Status
- Temporarily Not Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Orca Biosystems, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- —
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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Orca-T | Orca-T that does not meet commercial release specifications |
Timeline
- First posted
- 2026-01-16
- Last updated
- 2026-01-16
Source: ClinicalTrials.gov record NCT07346105. Inclusion in this directory is not an endorsement.