Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
NCT06617572 · Status: AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2026-08-11
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
- Synovial Sarcoma
- Myxoid Liposarcoma
Interventions
- GENETIC
-
Non-conforming afamitresgene autoleucel
Non-conforming afamitresgene autoleucel, suspension for intravenous infusion (NC afami-cel), single dose administration
Sponsors & Collaborators
-
USWM CT, LLC
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
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