Trials / Available
AvailableNCT06617572
Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
Expanded Access Protocol for Product Which Does Not Conform to the TECELRA® (Afamitresgene Autoleucel, Suspension for Intravenous Infusion) Commercial Release Specification
- Status
- Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- USWM CT, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | Non-conforming afamitresgene autoleucel | Non-conforming afamitresgene autoleucel, suspension for intravenous infusion (NC afami-cel), single dose administration |
Timeline
- First posted
- 2024-09-27
- Last updated
- 2026-02-09
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06617572. Inclusion in this directory is not an endorsement.