OmnImmune® for the treatment of Acute Myeloid Leukaemia

• Research type

  Research Study

• Full title

  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 with high dose salvage chemotherapy and/or allogeneic Haematopoietic Cell Transplantation (HCT). A dose escalation, open-label, phase I study.

• IRAS ID

  273193

• Contact name

  Tomasz Zaremba

• Contact email

  clinical@tcbiopharm.com

• Sponsor organisation

  TC BioPharm, Ltd.

• Eudract number

  2018-000409-22

• Duration of Study in the UK

  2 years, 6 months, 0 days

• Research summary

  In this study the participants will receive the Investigational Medicinal Product 'OmnImmune®' (TCB-202) - a cell therapy treatment produced by expanding a component of the white blood (the Gamma Delta T Lymphocyte).
  The subjects will all have a diagnosis of a type of blood cancer - Acute Myeloid Leukaemia (AML) - and the treatment will be produced from the white cells of suitably matched donor relatives, extracted by a process called apheresis.
  The apheresis material from the donor is produced by a process of expanding the TC BioPharm manufacturing site in EuroCentral near Motherwell where the therapy is produced by a process of expanding the Gamma delta T lymphocytes.
  Prior to treatment the subject will receive a standard pre-conditioning chemotherapy treatment.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  19/SC/0582

• Date of REC Opinion

  9 Mar 2020

• REC opinion

  Further Information Favourable Opinion