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A phase I study investigating the safety and tolerability of an infusion of T lymphocytes transduced with an anti-Lewis Y (LeY) chimeric receptor gene in patients with LeY expressing solid tumours
Johnson & Johnson Pharmaceutical Research & Development
This study will test the safety, tolerability and effectiveness of an experimental treatment called â€œLeY CAR-T cell therapyâ€in treating solid tumours that carry the Lewis Y marker.
Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have an advanced solid tumour that is positive for the Lewis Y antigen.
The Lewis Y antigen is a molecule that coats the surface of a cancer cell and is not usually detected by T-cells. The â€œLeY CAR-T cell therapyâ€ may help the T-cells to find and destroy the cancer cells more easily. In this study, the T-cells will first be collected using a procedure called â€œApheresisâ€ that takes part before the study treatment. Apheresis collects some of the white blood cells (also called Leukocytes) including T-Cells from the blood. The collected T-cells will then be modified in the laboratory by a viral vector, to specifically target the cancer cells that have the Lewis Y marker on their surface.
After T-cells have been modified, the viral vector will be separated from modified T-cells and removed. Modified T-cells can now be called CAR-T cells. The finished LeY CAR-T cells will then be infused back into the body, without the viral vector.
As well as the LeY CAR-T cell therapy, patients will receive by lymphodepleting conditioning chemotherapy as intravenous fludarabine for 2 consecutive days prior to cell infusion to increase immunosuppression and improve persistence of engineered T-cells.
LeY CAR-T cell therapy is an experimental treatment. This means that it is not an approved treatment for LeY expressing solid tumours in Australia.