TCR2 Therapeutics is committed to bringing TRuC-T cells to patients with cancer. As part of that commitment, TCR2 conducts, alone or with our partners, clinical trials of our investigational medicines to demonstrate their safety and effectiveness for patients.
At this time, patients have the possibility to access our TRuC-T cells through our clinical trials. Eligibility criteria for these clinical trials are listed at www.clinicaltrials.gov. Patients interested in learning if enrollment in a clinical trial is an option for them should consult with their treating physician.
As part of the Expanded Access Program, TCR2 may consider providing our investigational medicines outside the clinical trial setting for patients with a serious and immediately life-threatening disease for which no satisfactory treatment alternative exists, and for whom it is not possible to participate in a clinical trial.
How Expanded Access Works at TCR2
TCR2 will make ethical and fair decisions, taking into consideration the particulars of each patient’s case, the available medical and scientific information, and the probability and timing of a regulatory approval. All decisions are guided by the following principles:
- the request has been made by a qualified and licensed physician with expertise in the relevant area of medical practice;
- the request is for a TCR2 investigational medication currently under clinical development or pending regulatory approval;
- the patient does not qualify for participation in ongoing or pending clinical trials; the patient to be treated has a serious and immediately life-threatening disease and there is no satisfactory treatment alternative;
- the patient’s underlying medical conditions do not pose safety risks that have not been sufficiently studied;
- the patient’s condition is of a type and stage commensurate with the indication for which the investigational medicine is likely to be approved;
- the potential benefit of the investigational medicine to the patient is greater than the potential risk;
- there is an adequate supply of the investigational medicine;
- it has been established that the necessary facilities and resources are (or will be) in place to ensure the investigational medicine can be safely and correctly administered, and that the therapy with the investigational medicine will be sufficiently monitored and managed, and further that the reporting of side effects and patient experience will occur; and
- it has been established that access to the investigational medication will not compromise future or ongoing clinical trials in a way that may delay access to such investigational medication to other patients.
Procedure to Request Expanded Access
A request for expanded access to a TCR2 investigational medicine must originate directly from a licensed physician on behalf of the patient and should be forwarded to TCR2 at ExpandedAccess@TCR2.com. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals, as applicable, and to comply with all other safety, monitoring, reporting, and patient consent requirements defined by TCR2. Please do not send personal health identifying information (PHI) in this request.
If a request for expanded access to an investigational medicine originates from a country in which TCR2 has partnered with another company, the request for expanded access should be originated by a licensed physician on behalf of the patient and directed to the TCR2 partnered company.
TCR2 anticipates acknowledging receipt of requests for expanded access within five (5) business days.