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A Phase 1a/1b, Open-label First-in-human Study of the Safety, Tolerability and Feasibility of Gene-edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors

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Trial Profile

A Phase 1a/1b, Open-label First-in-human Study of the Safety, Tolerability and Feasibility of Gene-edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors

Status: Suspended
Phase of Trial: Phase I

Latest Information Update: 16 May 2023

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At a glance

  • Drugs NeoTCR-P1 (Primary) ; Nivolumab (Primary) ; Aldesleukin; Interleukin-2
  • Indications Advanced breast cancer; Colorectal cancer; Malignant melanoma; Ovarian cancer; Prostate cancer; Solid tumours; Urogenital cancer
  • Focus Adverse reactions; First in man
  • Sponsors PACT Pharma

    • Most Recent Events

    • 19 Apr 2023 Results(n=2) Monitoring of neoantigens and adoptively transferred personalized neoTCR T cell populations in the tumor and PBMCs of patients with solid tumors presented at the 114th Annual Meeting of the American Association for Cancer Research
    • 08 Mar 2023 According to a PACT Pharma media release, results of this phase 1 trial were published in Nature paper and can be accessed at: https://www.nature.com/articles/s41586-022-05531-1.
    • 01 Mar 2023 Results of a clinical-grade approach based on CRISPR-Cas9 non-viral precision genome-editing to simultaneously knockout the two endogenous TCR genes TRAC (which encodes TCRalpha) and TRBC (which encodes TCRbeta), published in the Nature.

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