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Safety and Efficacy of Ex-vivo Expanded Allogeneic γδ T-lymphocytes (OmnImmune) in Patients With Active Relapsed or Refractory Acute Myeloid Leukaemia (AML) Who Are Not Eligible for or do Not Consent to High Dose Salvage Chemotherapy and/or Allogeneic Haematopoietic Cell Transplantation (HCT). A Dose Escalation, Open-label, Phase I Study

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Trial Profile

Safety and Efficacy of Ex-vivo Expanded Allogeneic γδ T-lymphocytes (OmnImmune) in Patients With Active Relapsed or Refractory Acute Myeloid Leukaemia (AML) Who Are Not Eligible for or do Not Consent to High Dose Salvage Chemotherapy and/or Allogeneic Haematopoietic Cell Transplantation (HCT). A Dose Escalation, Open-label, Phase I Study

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 23 Feb 2023

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At a glance

  • Drugs TCB 002 (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; First in man
  • Sponsors TC BioPharm

Most Recent Events

  • 21 Feb 2023 According to TC Biopharm media release, the company announces the publication of paper titled "A Phase I trial of allogeneic T lymphocytes from haploidentical donors in patients with refractory or relapsed acute myeloid leukemia" n Clinical Lymphoma, Myeloma and Leukemia, a monthly peer reviewed journal.
  • 17 Mar 2022 According to a TC BioPharma media release, FDA orphan drug status has been granted for OmnImmune for use in acute myeloid leukemia, based on data from this trial.
  • 08 Mar 2022 Interim results(n=7) published in TC BioPharm Media Release.

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