Source: FDA, National Drug Code (US) Revision Year: 2024
TECELRA (afamitresgene autoleucel) is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy product consisting of CD4 and CD8 positive T cells transduced with a self-inactivating lentiviral vector (LV) expressing an affinity-enhanced T cell receptor (TCR) specific for the human MAGE-A4.
Autologous T cells transduced with MAGE-A4-c1032 LV express the affinity-enhanced TCR on the cell surface. The TCR recognizes an HLA-A*02 restricted MAGE-A4 peptide. MAGE-A4 is an intracellular cancer-testis antigen that has restricted expression in normal tissues and is expressed in synovial sarcoma.
TECELRA is prepared from the patient's peripheral blood mononuclear cells (PBMCs), which are obtained via a standard leukapheresis procedure. The PBMCs are enriched for T cells and are then transduced with a replication-incompetent LV containing the MAGE-A4 TCR transgene. The transduced T cells are expanded, washed, formulated into a suspension, and cryopreserved. The product must pass a sterility test before release and shipping as a frozen suspension in one or more infusion bag(s). The product is thawed prior to infusion back into the patient [see Preparation and Administration (2.2), How Supplied/Storage and Handling (16)].
The drug product formulation contains 5% dimethyl sulfoxide (DMSO).
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TECELRA is a cell suspension for intravenous infusion. A single dose of TECELRA contains 2.68 x 109 to 10 x 109 MAGE-A4 TCR positive T cells in one or more infusion bag(s) [see How Supplied/Storage and Handling (16)]. |
| How Supplied |
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TECELRA is supplied in one or more infusion bag(s) containing a frozen suspension of genetically modified autologous T cells in 5% DMSO. Each TECELRA infusion bag is individually packed in a metal cassette. Product and patient-specific labels are located on both the product infusion bag(s) and the protective shipping cassette(s). Each infusion bag (250 ml) is contained within a protective metal cassette (NDC 83205-0001-2). TECELRA is shipped in a liquid nitrogen dry vapor shipper at less than or equal to -130°C. Manufactured by: Adaptimmune, LLC, 351 Rouse Boulevard, Philadelphia, PA 19112 |
| Drug | Countries | |
|---|---|---|
| TECELRA | United States |
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