This study is not accepting new patients

Orca-T Expanded Access Program Study for Patients With Advanced Hematologic Malignancies

a study on Hematologic Malignancy Acute Myeloid Leukemia Leukemia Myelodysplastic Syndrome Hematologic Neoplasms Lymphoma

Summary

Location
at UCLA
Dates
study started

Description

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

Keywords

Hematologic Malignancies, Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Myelodysplastic Syndrome, Mixed Phenotype Acute Leukemia, Hematopoietic stem cell transplantation, Acute leukemia, Myelodysplastic syndromes, Matched related donor, Matched unrelated donor, TREGZI, Hematologic Neoplasms, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Biphenotypic, Acute, Orca-T

Eligibility

You can join if…

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 CAN'T join 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.

Locations

  • UCLA Department of Medicine - Hematology/Oncology not accepting new patients
    Los Angeles California 90095 United States
  • Stanford Cancer Institute not accepting new patients
    Palo Alto California 94304 United States

Details

Status
not accepting new patients
Start Date
Sponsor
Orca Biosystems, Inc.
ID
NCT07346105
Study Type
Expanded Access
Last Updated
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