Phase I/II study evaluating AUTO2 in patients with multiple myeloma V1
Research type
Research Study
Full title
A Single Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO2, a CAR T Cell Treatment Targeting BCMA and TACI, in Patients with Relapsed or Refractory Multiple Myeloma
IRAS ID
208047
Contact name
Rakesh Popat
Contact email
Sponsor organisation
Autolus Ltd
Eudract number
2016-003893-42
Duration of Study in the UK
3 years, 6 months, 0 days
Research summary
Multiple Myeloma (myeloma for short) is a bone-marrow cancer. Patients with myeloma suffer from bone-marrow failure, infections, kidney failure and bone-fractures. There are several treatments available, including chemotherapy, which can treat myeloma. However, none of these treatments can cure the disease and most patients eventually relapse. New ways of treating myeloma are needed.
T-cells are white blood cells which are the 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. Medical science has long sought to harness T-cells to fight cancer cells, however since cancer cells develop from our own cells, T-cells do not recognise any foreign viral proteins and do not target them. This clinical study tests a way of "re-programming" T-cell so they recognise myeloma cancers.
T-cells are present in blood; to harvest a large number of T-cells, patient enrolled to this study will have a medical procedure called leukapheresis. This procedure 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" or CAR for short. This CAR allows the T-cells to recognise myeloma cells. The CAR T-cells are given back to the patient through an intravenous drip.
Patients recruited to this study will have myeloma which no longer responds to standard treatment. The first part of this study will test increasing doses of CAR T-cells to find a safe and effective dose. The second part of the study will begin to see how effective the CAR T-cells are at the selected dose.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/2008
Date of REC Opinion
10 Feb 2017
REC opinion
Further Information Favourable Opinion