Cambridge Massachusetts online Form 13551 2023-2025

Cambridge Massachusetts online Form 13551: What You Should Know

S. Food and Drug Administration (FDA) announced that it has determined that Bristol Myers Squibb and bluebird bio Inc. has demonstrated through scientific and clinical testing data (i.e., a trial that has shown an effective and well-tolerated anticancer effect on a Murine model of bladder carcinoma, called TEAS) that its QST-1822 CAR T Cell (CAR-T) Therapy CAR is safe and effective in humans and may help prevent or delay or reduce bladder cancer. The FDA has granted approval for the CAR clinical trial for a Phase I clinical trial. Bristol Myers Squibb and bluebird bio are seeking a few human clinical trial subjects for the CAR T Cell Therapy CAR study. Participants are being recruited from the community outside of Bristol Myers Squibb and bluebird bio's research facilities, such as a patient or family member who have not been enrolled by, or selected for enrollment into, a clinical trial. Each patient will be asked to apply for enrollment in or participate in a clinical trial. Each patient will be required to provide a minimum of 2 references (if necessary), a consent form that has been approved by an institutional review board (IRB), and the name of an individual physician willing to act on behalf of the participant/patient (if necessary). If a patient declines to participate and the clinical trial is not completed, then a new application for enrollment in another clinical trial will be required. If the participant has been enrolled by an IRB and cannot complete the clinical trial, he will be automatically enrolled within 1 year and the enrollment request will be forwarded to this third party for review and evaluation. The third party will determine if the trial has progressed appropriately and if so, evaluate the participant and determine if the trial must be stopped and the participant's benefits reviewed. In addition, if the participant continues to be a part of a clinical trial regardless of how he responds to the therapy, the trial will continue. No more than 3 of the 5 participants enrolled will be eligible to participate in the full trial or will have to be dropped to continue with alternative therapies. The full clinical trials will continue through the end of July 2017. No person should experience side effects with CAR at any time.

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