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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-conforming afamitresgene autoleucel | Genetic | Non-conforming afamitresgene autoleucel, suspension for intravenous infusion (NC afami-cel), single dose administration |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Scientist | Contact | 866-750-8796 | kathleen.derose@usworldmeds.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Arizona | Available | Phoenix | Arizona | 85259 | United States |
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| ID | Term |
|---|---|
| D013584 | Sarcoma, Synovial |
| D018208 | Liposarcoma, Myxoid |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Stanford Hospital and Clinics | Available | Stanford | California | 94305 | United States |
|
| Mayo Florida | Available | Jacksonville | Florida | 32224 | United States |
|
| Moffit Cancer Center | Available | Tampa | Florida | 33612 | United States |
|
| Northwestern University Feinberg School of Medicine | Available | Chicago | Illinois | 60601 | United States |
|
| Massachusetts General Hospital | Available | Boston | Massachusetts | 02144 | United States |
|
| Dana-Farber Cancer Institute | Available | Boston | Massachusetts | 02215 | United States |
|
| Mayo Rochester | Available | Rochester | Minnesota | 55905 | United States |
|
| Memorial Sloan Kettering Cancer Centre | Available | New York | New York | 10065 | United States |
|
| Fox Chase Cancer Center | Available | Philadelphia | Pennsylvania | 19111 | United States |
|
| MD Anderson Cancer Center | Available | Houston | Texas | 77030 | United States |
|
| D012509 | Sarcoma |
| D008080 | Liposarcoma |
| D018205 | Neoplasms, Adipose Tissue |