Expanded access to investigational medicines
At Caribou, we are committed to developing transformative genome-edited allogeneic, or off-the-shelf, cell therapies, including chimeric antigen receptor T (CAR-T) cell therapies for hematologic malignancies and CAR-NK cell therapies for solid tumors. These investigational therapies have not yet been approved by regulatory authorities, such as the U.S. Food and Drug Administration (FDA). We are focused on conducting the clinical trials necessary to apply for regulatory approvals to make our allogeneic cell therapies broadly available to patients.
“Expanded access” refers to the use of an investigational therapy outside of a clinical trial for the potential treatment of a serious or immediately life-threatening condition. At this time, Caribou does not have active expanded access protocols nor does it currently provide access to its investigational therapies on an expanded access basis.
We believe the best way to develop therapies that may provide benefits for the largest number of patients is to conduct rigorous clinical development programs. Participation in one of our clinical trials is the best and preferred route to access these investigational products. Patients and physicians interested in Caribou’s investigational therapies are encouraged to learn more about the company’s ongoing clinical trials by visiting the clinical trials section of the Caribou website or clinicaltrials.gov and searching for Caribou Biosciences.
Physicians with questions about participating in one of Caribou’s clinical trials can submit a request to firstname.lastname@example.org.
Caribou will acknowledge receipt of requests and respond to inquiries within approximately 5 business days.
Caribou Biosciences periodically reviews its policies to ensure conformity with applicable laws and regulations and reserves the right to revise this position at any time.