Expanded Access Program for Afami-cel Treatment
Sponsor: Adaptimmune
ClinicalTrials ID:NCT06617572
This program allows patients to access a specific form of Afami-cel treatment that doesn't meet standard commercial specifications. It's available at certain treatment centers where TECELRA® is used, and patients must meet specific criteria to participate.
Patient Parameters
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Program Overview
The goal of this program is to provide access to a version of Afami-cel, a treatment given through an IV, that doesn't meet the usual commercial standards. This is available at approved centers where TECELRA® is already being used. Patients who are prescribed TECELRA®, agree to the terms, and meet all the necessary conditions can join this program.
Eligibility Criteria
Inclusion Criteria
- Must agree to participate and sign a consent form.
- Must have been prescribed TECELRA®.
- The standard version of the treatment isn't suitable for the patient.
- It's not possible or appropriate to make the treatment again, as decided by the doctor and Adaptimmune.
- It's not possible or appropriate to collect blood cells again, as decided by the doctor.
- The doctor, after evaluating the treatment, believes the benefits outweigh the risks and it's in the patient's best interest to proceed.
- Must be healthy and stable enough to receive the treatment, as assessed by the doctor.
- Women who can become pregnant must have a negative pregnancy test within 7 days before starting chemotherapy.
Exclusion Criteria
- Cannot participate if there are any reasons listed in the TECELRA® guidelines that prevent use.
- Cannot use TECELRA® if you have a specific genetic marker (HLA-A*02:05P).
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