Phase I/II study - AUTO4 in patients with T cell non-Hodgkin Lymphoma
Research type
Research Study
Full title
A Single Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO4, a CAR T Cell Treatment Targeting TRBC1, in Patients with Relapsed or Refractory TRBC1 positive selected T Cell Non-Hodgkin Lymphoma.
IRAS ID
232371
Contact name
Neil Bell
Contact email
Sponsor organisation
Autolus Ltd
Eudract number
2017-001965-26
Duration of Study in the UK
4 years, 10 months, 31 days
Research summary
T cell lymphoma represents approximately 3-4% of haematological malignancies and between 10-20% of non-Hodgkin lymphomas (NHL). T cell lymphoma is an aggressive disease with a poor prognosis. During T cell development, each T cell generates a unique T cell receptor (TCR). A characteristic of TCR gene rearrangement is that a coding sequence is duplicated and two versions are created (TRBC1 and 2). Malignant T cells are clonal and are entirely TRBC1 or TRBC2 positive. This study will test AUTO4 which will target only the TRBC1 positive T cells leaving the remainder of normal T cells intact. The study will therefore only recruit patients with TRBC1 positive lymphomas.
This is a new approach and will take the patient's own T cells and re-program them to recognize and destroy the lymphoma cells. To test this, in this study, the patient's T cells will be harvested from the blood using a medical procedure called leukapheresis. The leukapheresate is transferred to a laboratory where the T cells are genetically modified to express a new gene, the aTRBC1-CAR. This gene instructs the T cells to make a new protein called a "chimeric antigen receptor" (CAR) which allows the T cells to recognise and kill TRBC1 positive lymphoma cells. Once a sufficient quantity of CAR expressing T cells are manufactured, the drug product is given back to the patient via an intravenous drip.
These CAR T cells are the product that is being tested - called AUTO4.The study has two phases. The first phase of the study is to test the safety of AUTO4 and to find the recommended dose of AUTO4. The second phase of the study will evaluate how effective AUTO4 is at killing the lymphoma cancer cells – that is, the efficacy of AUTO4. The evaluation of the AUTO4 safety will continue throughout the study.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/1730
Date of REC Opinion
16 Jan 2018
REC opinion
Further Information Favourable Opinion