Trials / Available
AvailableNCT05398640
Expanded Access Program of AMTAGVI That is Out of Specification for Commercial Release
- Status
- Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Iovance Biotherapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.
Detailed description
This program provides access to OOS AMTAGVI (lifileucel) that does not meet commercial release criteria but does meet Iovance clinical trial release criteria. Patients will be followed for safety and efficacy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | OOS AMTAGVI | Patients will undergo preparative lymphodepleting chemotherapy. Infusion of lifileucel is then given and is followed by administration of IL-2. |
Timeline
- First posted
- 2022-06-01
- Last updated
- 2025-06-17
Locations
33 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05398640. Inclusion in this directory is not an endorsement.