FRACTALL
Research type
Research Study
Full title
Fratricide-Resistant Autologous Chimeric Antigen Receptor T cells targeting CCR9 for the treatment of T cell Acute Lymphoblastic Leukaemia/ Lymphoma
IRAS ID
1007887
Contact name
Paul Maciocia
Contact email
Sponsor organisation
University College London
Eudract number
2022-003497-23
ISRCTN Number
ISRCTN15341827
Research summary
T cell Acute Lymphoblastic Leukaemia (T-ALL) and T cell Lymphoblastic Lymphoma (T-LBL) are aggressive cancers that are hard to cure. Often, the cancer does not respond to treatment or comes back afterwards. For these patients, treatment options are limited and usually involve intensive chemotherapy followed by a stem cell transplant. However, chemotherapy often fails, and many patients are too unwell for a transplant. Even when possible, transplants carry serious risks and long-term side effects. There is an urgent need for safer, more effective therapies.
The FRACTALL study is testing a new product called CAR-T cells (short for Chimeric Antigen Receptor T cells) in patients with T-ALL or T-LBL whose disease has not responded to treatment or has returned after initial success. T cells are part of the immune system and help fight infections. In CAR-T therapy, we take a patient’s own T cells and modify them in the lab so they can recognise and kill cancer cells. These reprogrammed cells are called CAR-T cells. CAR-T cells have already shown success in another type of leukaemia called B-ALL, leading to long-term remissions in many patients. There is growing evidence that CAR-T therapy may also work in T-ALL and T-LBL.
In this study, we are developing a new type of CAR-T cell that targets a marker called CCR9, found on most cancerous T cells. We will collect T cells from each patient’s blood, modify them to recognise CCR9, and then give them back to the patient.
The main goals of the study are to find out if this new CAR T cells are safe and to determine the best dose. We plan to give the cells to 12 children (under 18) and 12 adults.
Patients will receive a short course of chemotherapy before getting the CAR-T cells, which are given through a drip. They will stay in hospital for at least two weeks and be closely monitored. After leaving hospital, they will return for regular check-ups for two years, including blood tests, scans, and sometimes bone marrow tests.REC name
London - West London & GTAC Research Ethics Committee
REC reference
25/LO/0356
Date of REC Opinion
15 Jul 2025
REC opinion
Further Information Favourable Opinion