COBALT
Research type
Research Study
Full title
Evaluation of CAR19 T-cells as an optimal bridge to allogeneic transplantation.
IRAS ID
173780
Contact name
Nick McNally
Contact email
Eudract number
2015-000348-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 1 months, 29 days
Research summary
Research Summary:
Patients with an aggressive form of cancer called Diffuse Large B Cell Lymphoma (DLBCL) can often be cured with chemotherapy. However, for those with disease that fails to respond adequately or that relapses following initial treatment, the numbers of effective treatment options are very limited. Bone marrow/stem cell transplantation is one of the few treatments that can cure such patients, but in most cases it is not possible to control the cancer sufficiently to allow the transplant to be performed. New treatments are now being developed that redirect the patient’s own immune system to attack the cancer, and amongst the most exciting of these are CAR T cell therapies. CAR stands for Chimeric Antigen Receptor. It is a way to direct the immune cells to specifically recognise and attack the cancer cells. Patients have been shown to respond to CAR-redirected T-cell therapies, including patients with DLBCL. Whilst the depth and durability of such responses remains unknown, these therapies might prove an effective way to gain sufficient control of the cancer to allow a bone marrow/stem cell transplant to be performed (forming a ‘bridge to transplantation’). Our study aims to assess the safety and feasibility of CAR T cell therapy, and to provide preliminary insight into how effective this ‘bridge to transplantation’ strategy may be.Lay summary of study results:
Patients with an aggressive form of cancer called Diffuse Large B Cell Lymphoma (DLBCL) can often be cured with chemotherapy. However, for those with disease that fails to respond adequately or that relapses following initial treatment, the numbers of effective treatment options are very limited. Bone marrow/stem cell transplantation is one of the few treatments that can cure such patients, but in most cases it is not possible to control the cancer sufficiently to allow the transplant to be performed.
Chimeric antigen receptor T-cells (CAR T-cells) have shown considerable promise in the treatment of haematological cancers, with several products now approved for treatment. CAR-T cells redirect the patient’s own immune system to attack the cancer.
Patients have been shown to respond to CAR-redirected T-cell therapies, including patients with DLBCL. Whilst the depth and durability of such responses remains unknown, these therapies might prove an effective way to gain sufficient control of the cancer to allow a bone marrow/stem cell transplant to be performed (forming a ‘bridge to transplantation’).
Generating CAR T-cell products requires significant resources, a complex manufacturing method, and a skilled team of specialised staff. As demand for CAR T-cell products increase, new methods of manufacture are needed to establish large-scale provision.
The COBALT study aimed to assess the safety and feasibility of CAR T cell therapy, provide preliminary insight into how effective this ‘bridge to transplantation’ strategy may be.
The trial recruited 10 participants over 42 months, 10 products were successfully manufactured and 9 patients were administered their CAR T-cell product.
A full detailed publication of results is currently under review and will be linked here when available.
We would like to thank all patients and their families who participated on COBALT, the participating sites and their staff for their support of the study . We also thank Bloodwise for funding the project.REC name
London - West London & GTAC Research Ethics Committee
REC reference
15/LO/1509
Date of REC Opinion
10 Dec 2015
REC opinion
Further Information Favourable Opinion