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  • reshamn replied to the topic Unexpected Clinical Study Results in the forum Clinical Trials for Medical Devices 7 years ago

    Nowadays, most people are entering for a clinical trial that involves a cancer immunotherapy but they are at an advanced stage of the disease. Recently, there have been deaths related to this kind of trial and have put researchers on edge because they don’t understand as to why was there a reaction. There are autoinflammatory responses that they don’t fully about. Several patients died in the Cellectis and Juno trial. The Juno and Cellectis trials gave CAR T cells to the participants after pretreating the individuals with fludarabine, a chemotherapy drug that depletes the body of T cells, so that the population of engineered cells has a better chance to expand. After the death, the company suggested that perhaps the problem was with the interaction of fludarabine and the drug. The FDA approved continuing the trial just with the drug. But then, two more patients died and at that point it came to a complete halt.

    Therefore, sometimes with the extent of the disease, patients react to the same drug in different ways. Clinical trial have to be conducted very carefully and monitoring each checkpoint in the patient’s health.