Trialling a new way to boost CAR T-cell therapy

3D rendering of blood cancer

3D rendering of blood cancer

Cancer Research UK is collaborating with Aleta Biotherapeutics (Aleta) to trial a new therapy that ‘reboots’ a treatment for some people with blood cancer whose cancer starts to come back.

The new therapy, called ALETA-001, aims to boost a treatment called CAR T-cell therapy, which takes some of a patient’s immune cells and alters them to attack cancer.

Cancer Research UK’s Centre for Drug Development will fund, sponsor and conduct the clinical trial of ALETA-001, which will involve people with B cell lymphoma and leukaemia.

Nigel Blackburn, Cancer Research UK’s director of drug development, said this is a landmark collaboration for Cancer Research UK.

“It’s the first-in-human trial for a new drug that reboots CAR T-cell therapy, and we look forward to progress its early clinical development with Aleta.”

Rebooting CAR T-cell therapy

CAR T-cell therapy works by taking some of a patient’s T cells and altering them to recognise a particular protein found on lymphoma and leukaemia cells, called CD19. After a few weeks, these cells are then fed back into the bloodstream and attack cancer cells.

“CAR T-cell therapy has been transformative in treating patients with hard-to-treat blood cancers, but many will see their cancer return and treatment options begin to run out,” said Blackburn.

Around half of the patients treated with CAR T-cell therapy relapse, mostly because their cancer cells stop producing the CD19 protein that CAR T-cells are looking for.

When this happens, patients have few other options.

ALETA-001 acts as a ‘reboot’ for CAR T-cell therapy, attaching to a different protein called CD20 and ‘recoating’ the cancer cell with CD19. The CAR T-cells can then recognise and attack the cancer cells again.

“ALETA-001 uses a simple yet elegant method to redirect a patient’s circulating CD19 CAR T-cells against cancer cells expressing CD20, and we hope this could be a new treatment avenue for blood cancer,” said Blackburn.

Taking ALETA-001 to the clinic

The first trial will enrol patients with B cell lymphoma or leukaemia who have received CD19 CAR T-cell therapy but did not achieve a complete response or whose cancer has come back.

Led by a team at The Christie NHS Foundation Trust in Manchester, it will be the first time that this type of therapy has ever been tested in humans.

A key aim of the trial is to find out the right dosage of ALETA-001. After this, it will be move into a much bigger trial in the US involving people with diffuse large B cell lymphoma.

This second trial will be designed to support potential accelerated approval of ALETA-001 for cancer patients.

Paul Rennert, President, co-founder and chief scientific officer of Aleta Biotherapeutics, said: “There is an urgent need to develop new therapies that can help people with B cell cancers, such as lymphoma and leukaemia, whose cancer has progressed after treatment with CD19 CAR T-cell therapy.”

“We look forward to working with Cancer Research UK’s exceptional network of experienced clinical trial investigators and researchers to conduct the trial.”

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