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A Phase 1/2, First-in-Human, Open-Label, Accelerated-Titration, Two-Part Clinical Trial of TK-8001 (MAGE-A1-Directed TCR-Transduced Autologous CD8+ T-cells) in Patients With HLA-A*02:01 Genotype and Advanced-Stage/Metastatic, MAGE-A1+ Solid Tumors That Either Have No Further Approved Therapeutic Alternative(s) or Are Not Eligible for Them or Are in a Non- Curable State and Have Received a Minimum of Two Lines of Systemic Therapy

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Trial Profile

A Phase 1/2, First-in-Human, Open-Label, Accelerated-Titration, Two-Part Clinical Trial of TK-8001 (MAGE-A1-Directed TCR-Transduced Autologous CD8+ T-cells) in Patients With HLA-A*02:01 Genotype and Advanced-Stage/Metastatic, MAGE-A1+ Solid Tumors That Either Have No Further Approved Therapeutic Alternative(s) or Are Not Eligible for Them or Are in a Non- Curable State and Have Received a Minimum of Two Lines of Systemic Therapy

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 13 Feb 2024

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At a glance

  • Drugs TK 8001 (Primary)
  • Indications Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms IMAG1NE
  • Sponsors T-Knife
  • Most Recent Events

    • 05 Feb 2024 Status changed from suspended to discontinued (Sponsor decision).
    • 20 Dec 2023 Status changed from recruiting to suspended.
    • 20 Oct 2022 According to a T-knife Therapeutics media release, first patient has been dosed in this trial.

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