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Orca T - Orca Bio

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Drug Profile

Orca T - Orca Bio

Alternative Names: Orca-T; TregCD34; TregGraft; TRGFT-201

Latest Information Update: 28 Jan 2026

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At a glance

  • Originator Orca Bio; Stanford University
  • Class Antineoplastics; Gene therapies; Immunotherapies; T lymphocyte cell therapies
  • Mechanism of Action Immunologic cytotoxicity; T lymphocyte replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Haematological malignancies
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Acute myeloid leukaemia; Myelodysplastic syndromes; Precursor cell lymphoblastic leukaemia-lymphoma
  • Phase I/II Lymphoid leukaemia; Myelofibrosis
  • Phase I Haematological malignancies

Most Recent Events

  • 28 Jan 2026 No recent reports of development identified for phase-I development in Precursor-cell-lymphoblastic-leukaemia-lymphoma(Combination therapy, Second-line therapy or greater) in USA (IV)
  • 16 Jan 2026 Expanded access program is no longer available for Orca T for Haematological malignancies (Late-stage disease) (NCT07346105)
  • 16 Jan 2026 Orca Biosystems initiates an Expanded access programme (EAP) for Haematological malignancies (Late-stage disease), prior to January 2026 (NCT07346105)

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