AMELIA

• Research type

  Research Study

• Full title

  A Single Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO3, a CAR T Cell Treatment Targeting CD19 and CD22 in Paediatric and Young Adult Patients with Relapsed Refractory B-cell Acute Lymphoblastic Leukaemia.

• IRAS ID

  220370

• Contact name

  Neil Bell

• Contact email

  n.bell@autolus.com

• Sponsor organisation

  Autolus Ltd

• Eudract number

  2016-004680-39

• Duration of Study in the UK

  4 years, 2 months, 1 days

• Research summary

  Acute lymphoblastic leukaemia (ALL) is a blood cancer that is common in children, affecting around 420 patients aged 24 years old and younger in the UK per year. There are several treatments available, including chemotherapy and stem cell or bone marrow transplant. However, some patients relapse and have a very low chance of cure with conventional treatments. New ways of treating relapsed ALL are needed.
  T-cells are white blood cells which are part of our immune system. Their function is to move around our bodies on a "seek-and-destroy" against cells in our body infected with a virus. Medicine has long sought to harness T-cells to fight cancer, however because cancer cells develop from our own cells, T-cells do not readily target them. This study tests a way of "re-programming" T-cells so they recognise ALL cells.
  The study involves harvesting T-cells which are present in blood; to harvest enough T-cells, patients in this study will have a medical procedure called leukapheresis. This involves passing blood from the patient through a machine which separates out white blood cells and returns the rest of the blood to the patient. The patient's own T-cells are taken to a specialised laboratory. Here, a new gene is inserted into the T-cells. This gene instructs the T-cells to make a new protein called a "chimeric antigen receptor" (CAR). This CAR allows the T-cells to recognise and kill ALL cells.
  The CAR T-cells are given back to the patient via an intravenous drip.
  Patients in this study will have ALL which has come back and no longer responds to standard treatment. The first phase of this study will test the safety and dosing of CAR T-cells. The second phase of the study will begin to see how effective the CAR-T cells using the best dose method found in the first phase.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  17/LO/0506

• Date of REC Opinion

  14 Jun 2017

• REC opinion

  Further Information Favourable Opinion