NCT07346105

Brief 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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

First QC Date

January 7, 2026

Last Update Submit

January 7, 2026

Conditions

Hematologic MalignanciesAcute Myeloid LeukemiaAcute Lymphoid LeukemiaMyelodysplastic SyndromeMixed Phenotype Acute Leukemia

Keywords

Hematopoietic stem cell transplantationAcute leukemiaMyelodysplastic syndromesMatched related donorMatched unrelated donorMyelodysplastic syndrome

Interventions

Orca-TBIOLOGICAL

Orca-T that does not meet commercial release specifications

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Recipients in this EAP must meet all of the following criteria:
  • Commercial Orca-T was prescribed to the patient by their treating physician.
  • The final manufactured Orca-T does not meet the commercial release specifications or is delivered past expiry.
  • 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.
  • Remanufacturing (ie, repeat leukapheresis and manufacturing) is not clinically appropriate per the treating physician's assessment.
  • Recipient must be deemed medically fit and stable to receive Orca-T infusions per the treating physician's evaluation.

You may not qualify 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Meyer EH, Salhotra A, Gandhi AP, Pantin J, Patel SS, Hoeg RT, Gomez-Arteaga A, Faramand R, Tamari R, Waller EK, Kosuri S, Jimenez Jimenez AM, Holter-Chakrabarty J, Dholaria B, Chen YB, Hamilton BK, Magenau J, Eghtedar A, Murray JM, Pavlova A, Fernhoff NB, McClellan JS, Killian MS, Li A, Negrin RS, Oliai C. Orca-T vs allogeneic hematopoietic stem cell transplantation (Precision-T): a multicenter, randomized phase 3 trial. Blood. 2026 Mar 12;147(11):1168-1177. doi: 10.1182/blood.2025031313.

    PMID: 41385341BACKGROUND

MeSH Terms

Conditions

Hematologic NeoplasmsLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaMyelodysplastic SyndromesLeukemia, Biphenotypic, Acute

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow Diseases

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 16, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01