Treatment with CD19/CD22 CAR redirected T cells for DLBCL- ALEXANDER
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 followed by consolidation with Anti PD1 Antibody in patients with relapsed or refractory diffuse large cell B Cell Lymphoma (DLBCL).
IRAS ID
226255
Contact name
Neil Bell
Contact email
Sponsor organisation
Autolus Ltd
Eudract number
2016-004682-11
Duration of Study in the UK
4 years, 6 months, 2 days
Research summary
Diffuse large B cell lymphoma (DLBCL) is a common, aggressive form of lymphoid cancer. Despite good response to initial therapies, a third of patients either do not respond to initial treatment or relapse following standard treatment. Most of these patients respond poorly to more chemotherapy and new ways of treating DLBCL are needed.
A new and promising approach is to take patient's own T-cells and re-program them to recognize and destroy the lymphoma cells. To test this, in this study patient's T cells will be harvested from the blood using a medical procedure called leukapheresis. This involves passing blood from the patient through a machine which spins the blood, separates out white blood cells and returns the rest of the blood to the patient. The T-cells are then taken to a specialised laboratory where a new gene is inserted into the T-cells using a modified virus which is not capable of multiplying. 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 lymphoma cells. Once a sufficient quantity of CAR T-cells is made they are given back to the patient via an intravenous drip.
The first phase of this study will test the safety and determine the best dose of CAR T-cells. Additionally, since cancer cell are known to apply brakes on the attacking T- cells (or CAR T cells), to prevent this from happening the patients will receive 3 doses of an anti-PD1 antibody, pembrolizumab as consolidation treatment starting approximately 2 weeks after AUTO3 infusion. The second phase of the study will evaluate how effectiveness of the selected dose of CAR-T cells followed by pembrolizumab consolidation therapy in a larger number of patients.REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/0812
Date of REC Opinion
19 Jul 2017
REC opinion
Further Information Favourable Opinion