A study of a new cell therapy for advanced cancers Disease Site Investigational New Drug Program Trial Code IND.246 ǀ NCT 07297667 Trial Status What is the purpose of this trial?The purpose of this study is to test the safety of a CAR-T (chimeric antigen receptor T cell) therapy. This study tests different doses of the new cell therapy in alveolar soft part sarcoma, renal cancer and breast cancer tumours to see which dose is safest for people.Why is this trial important?This is a new type of cell therapy being developed for the treatment of certain types of cancer that have a specific protein on the surface of their cells. Laboratory tests show that it may slow the growth of these types of cancers. This cell therapy has been tested in animals but has only been tested in one person and it is not clear if it can offer better results than standard treatment.Who can participate in this study?This trial is for people:diagnosed with alveolar soft part sarcoma, renal cell carcinoma (not clear cell) and triple negative breast cancerwho have completed all other available treatmentswith a life expectancy of at least 6 monthswith good access to their veins and who are healthy enough for the collection of their white blood cellsThis trial is not for people:who are being currently treated for another cancerwho have previously had other similar cellular therapy or therapies with the same target moleculewith active or uncontrolled infectionswith untreated and/or uncontrolled heart conditionsWhat are the risks?If you choose to take part in this study, there is a risk that the new therapy may not be as good as the standard treatment. There is also a risk that you could have side effects from the new therapy. This treatment has had minimal tested in humans, so the side effects are unknown at this time. The following have been described as most common side effects with similar treatments across a variety of types of cancer and patient populations and may or may not occur with the study treatment: lowering of blood cell counts (red blood cells, white blood cells and platelets) a group of symptoms associated with activation of your immune system (including high fever, malaise, fatigue, muscle aches and pain) a wide range of symptoms pertaining to the nervous system (difficulty thinking and confusion, disturbance in consciousness, difficulty speaking and understanding speech, involuntary muscle contractions).You will find details of all side effects in the consent document.What can I expect?If you choose to take part in this study, tissue from your tumour will be tested to see if a specific protein is present on your cells. If it is, and you meet all the study requirements, your white blood cells will be collected and will be genetically modified into the cell therapy. Once the cell therapy is prepared, you will receive standard chemotherapy to reduce the number of white blood cells to make space for the new, cancer-fighting immune cells that you will receive. You will then receive a single infusion of cell therapy.How can I find out more or join the study?Talk to your cancer doctor if you are considering joining this study. You can share summaries like this with them and ask if they think joining the trial may be a good option for you.Before you join this study, you will be asked to review an Informed Consent document which will tell you more about why the research is being done and your role as a participant. You will have an opportunity to discuss anything that is not clear and ask any questions you have.Joining this study is entirely up to you and you can decide to leave at any time without giving a reason. Your decision to join or leave the trial will not affect your standard medical care.The IND.246 study is currently enrolling patients at cancer centres in Canada. For a full list of participating cancer centres please visit www.clinicaltrials.gov and search using NCT07297667.Printable information sheet (pdf)Fiche d’information imprimable (pdf) Participating centres Information coming soon.
