Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorUSWM CT, LLC
About this trial
The purpose of this expanded access protocol (EAP) is to provide controlled access to Afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (NC afami-cel). This EAP will be conducted at authorized treatment centers where TECELRA® is being administered and where the EAP is approved to be conducted. Patients who are prescribed TECELRA® , sign the informed consent form, and meet all entry criteria will be eligible to participate in this protocol.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient must provide written informed consent prior to participating in this protocol
Patient must have been prescribed TECELRA®
Patient's commercially manufactured product does not meet the commercial release specification
Repeat manufacture is not feasible or is not clinically appropriate per Investigator assessment in consultation with per consultation with USWM CT
Disqualifiers
Patient has contraindication(s) as per the TECELRA® USPI
Do not use TECELRA® in adults who are heterozygous or homozygous for HLA-A*02:05P
Trial design
Treatments tested in this trial
Non-conforming afamitresgene autoleucel
GeneticNon-conforming afamitresgene autoleucel, suspension for intravenous infusion (NC afami-cel), single dose administration
Treatment groups
No treatment groups listed
Trial outcomes
This trial has no outcomes listed.Sponsors and contacts
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Source ClinicalTrials.gov