Expanded Access Policy

The Expanded Access Program (EAP), sometimes called compassionate use, is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

Expanded access may potentially be appropriate when all of the following apply:

• The patient has a serious or immediately life-threatening disease or condition.
• There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
• Patient enrollment in a clinical trial is not possible.
• There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information.
• Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

Given the early stage of our clinical development programs, participation in our clinical trials is the best way to access our investigational therapies. Therefore, our investigational products are not available through the EAP at this stage of development.

If you have additional questions, please speak with your physician, or have your physician contact ClinicalDevelopment@affinittx.com. We will address your request within five business days.

Affini-T Therapeutics may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record if such record becomes available.