Unum Therapeutics' Expanded Access Policy
Unum Therapeutics Inc. (Unum) is a clinical-stage biopharmaceutical company developing autologous cell therapies for patients with cancer.
Expanded access is a potential option for a patient to gain access to an investigational product outside of a clinical study. In line with guidelines from the US FDA and other regulatory agencies, expanded access may be appropriate when all of the following criteria are met:
· A patient has a serious or life-threatening condition with no other satisfactory treatment options;
· There is sufficient evidence that the potential patient benefit justifies the potential risks of treatment;
· Clinical study enrollment is not possible for the patient; and
· Provision of the investigational product via expanded access will not interfere with clinical studies that could support product development and marketing approval.
At this time, Unum does not offer an expanded access program for our investigational therapies. Unum believes that participation in one of our clinical studies is the most appropriate way to access our investigational therapies. Information on our active clinical studies can be found on www.clinicaltrials.gov.
Consistent with the 21st Century Cures Act, Unum may revise this policy at any time.