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Orca-T Expanded Access Program Study for Patients With Advanced Hematologic Malignancies
Sponsor: Orca Biosystems, Inc.
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.
Official title: An Expanded Access Program for Orca-T Products That Are Out of Specification for Commercial Release
Key Details
Gender
All
Age Range
Any - Any
Study Type
EXPANDED_ACCESS
Enrollment
Not specified
Start Date
Not specified
Completion Date
Not specified
Last Updated
2026-07-24
Healthy Volunteers
Not specified
Conditions
Interventions
Orca-T
Orca-T that does not meet commercial release specifications