Expanded Access Policy

Adaptimmune is committed to developing safe and effective therapies to transform the lives of people with cancer. Our goal is to provide access to our investigational therapies at the appropriate time or patients.

In general, patients obtain access to investigational therapies prior to regulatory approval by participating in clinical trials. There may, however, be circumstances when patients with a serious or life-threatening illness have exhausted all available treatment options and are not eligible to participate in any appropriate clinical trials. In those cases, patients may be eligible for treatment with an investigational therapy through programs referred to as ‘Expanded Access Programs’ (EAPs) or ‘compassionate use’. These programs help provide patients with a treatment outside the clinical trial setting that they would otherwise not be able to receive.

For a patient to get access to a therapy via an EAP, a doctor must decide whether the potential benefit outweighs the risk of receiving an investigational or unapproved therapy, based on the individual patient’s medical history.

Our Policy

Adaptimmune will consider a number of criteria - consistent with the US Food and Drug Administration (US FDA) and other regulatory agencies’ guidelines - when evaluating each request for access to our investigational therapies. Adaptimmune will consider granting expanded access to an investigational medicine only if all of the following threshold criteria are met:

• The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or enrolling clinical trials)
• The patient is ineligible or otherwise unable to participate in a clinical trial
• There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information
• Ability to provide a product in a fair and equitable manner, so that there is adequate manufacturing capacity for ongoing programs
• Whether granting expanded access would potentially compromise the scientific validity of broader development programs, or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients

What next?

If you are interested in obtaining access to an investigational medicine, you should discuss available options with your qualified treating physician. If an Adaptimmune clinical trial may be a good treatment option for you, we recommend that your doctor contact us on your behalf at patients@adaptimmune.com to discuss your specific medical condition and trial eligibility requirements.

If you are not eligible for an open or pending clinical trial, or if no appropriate clinical trials exist, and if your qualified treating physician believes that an EAP may be the best or only treatment option for you, please ask your doctor to contact Adaptimmune on your behalf at patients@adaptimmune.com.

Requests will be acknowledged within 5 business days of receipt. If after contacting Adaptimmune, your doctor is supportive of and committed to the requested treatment, he/she must submit a formal request to Adaptimmune for consideration.

Please note that submission of a request does not guarantee that access to the investigational therapy will be provided. Eligibility will be determined by Adaptimmune based on the established EAP and eligibility criteria for the investigational therapy concerned.

If the expanded access request is approved by Adaptimmune, the country regulatory authority from where the request originated will need to grant final approval before Adaptimmune can manufacture and ship the investigational medicine to the requesting physician. If approved for an EAP, your physician will work with you to address all logistical elements.

In line with the 21st Century Cures Act, Adaptimmune 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 on clinicaltrials.gov after such record becomes active.