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Mipetresgene autoleucel - Takara Bio

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Drug Profile

Mipetresgene autoleucel - Takara Bio

Alternative Names: NY-ESO-1 antigen-specific RetroNectin® TCR gene therapy - Takara Bio; NY-ESO-1 antigen-specific TCR-gene-transduced autologous lymphocytes - Takara Bio; NY-ESO-1 siTCR gene therapy; NY-ESO-1-antigen-specific-T-cell-receptor-gene-therapy; NY-ESO-1-specific-t-cells; NY-ESO-1-T-cells; NY-ESO-1-TCR; NY-ESO-1-TCR-gene-therapy-Takara; NY-ESO-1-TCR-PBMC; NY-ESO-1-TCR-transduced-lymphocytes; NY-ESO-1-transduced-t-cells; NY-ESO-1-transduced-t-lymphocytes; TBI-1301; TBI-1301A

Latest Information Update: 20 Jan 2026

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At a glance

  • Originator Takara Bio
  • Developer Fred Hutchinson Cancer Research Center; Mie University; National Cancer Institute (USA); Takara Bio; University Health Network
  • Class Antineoplastics; Gene therapies; Immunotherapies; T lymphocyte cell therapies
  • Mechanism of Action Gene transference; 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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase III Synovial sarcoma
  • Phase II Malignant melanoma
  • Phase I/II Soft tissue sarcoma
  • No development reported Sarcoma; Solid tumours; T-cell lymphoma

Most Recent Events

  • 05 Jan 2026 Phase-III clinical trials in Synovial sarcoma (Inoperable/Unresectable, Recurrent, Second-line therapy or greater) in Japan (IV) (NCT07174427)
  • 16 Sep 2025 Takara Bio plans a phase III trial for Synovial sarcoma (Inoperable/Unresectable, Recurrent) (IV), in November 2025 (NCT07174427)
  • 28 Dec 2024 No recent reports of development identified for phase-I development in Solid-tumours(Inoperable/Unresectable, Metastatic disease, Recurrent) in Canada (IV, Infusion)

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