Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Autolus GmbH, Im Schwarzenbach 4, 79576 Weil am Rhein, Germany
Aucatzyl 410 × 106 cells dispersion for infusion.
| Pharmaceutical Form |
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Dispersion for infusion. Colourless to pale yellow, very opalescent dispersion. |
Aucatzyl (obecabtagene autoleucel) is a genetically modified autologous cell-based product containing T cells transduced ex vivo using a lentiviral vector expressing an anti-CD19 chimeric antigen receptor (CAR), comprising a murine anti-CD19 single chain variable fragment linked to a 4-1BB co-stimulatory domain and a CD3-zeta signalling domain.
Each patient-specific infusion bag of Aucatzyl contains obecabtagene autoleucel at a batch-dependent viable CAR T cell concentration. Aucatzyl contains autologous T cells genetically modified to express an anti-CD19 CAR-positive viable T cells. The medicinal product is packaged in 3 or more infusion bags overall containing a cell dispersion for infusion of a total recommended dose of 410 × 106 CAR-positive viable T cells suspended in a cryopreservative solution. The dose range is 308 to 513 × 106 CAR-positive viable T cells.
The total volume of the treatment is split in 3 or more bags of variable volume containing (10 + 100 + 300) × 106 CAR-positive viable T cells, according to the posology (see section 4.2).
The quantitative information of medicinal product, including the number of infusion bags (see section 6) to be administered, is presented in the Release for Infusion Certificate (RfIC) and located inside the lid of the cryoshipper used for transporting the medicinal product.
Excipients with known effect:
This medicinal product contains 7.5% dimethyl sulfoxide (DMSO), up to 1 131 mg sodium and 39 mg potassium per total dose (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Obecabtagene autoleucel is an autologous immunotherapy consisting of the patient's own T cells engineered to express a CAR that recognises CD19 on-target cells via the murine CAT13.1E10 hybridoma (CAT) binding domain. Engagement of anti-CD19 (CAT) CAR-positive T cells with CD19-expressed on-target cells, such as cancer cells and normal B cells, leads to activation of the anti-CD19 (CAT) CAR-positive T cells and downstream signalling through the CD3-zeta domain. Proliferation and persistence by the anti-CD19 (CAT) CAR-positive T cells following activation are enhanced by the presence of the 4-1BB co-stimulatory domain. This binding to CD19 results in anti-tumour activity and killing of CD19-expressing target cells. |
| List of Excipients |
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Disodium edetate |
Ethylene vinyl acetate infusion bag(s) with a sealed filling tube and 2 available spike ports, containing either 10–20 mL (50 mL bags) or 30–70 mL (250 mL bags) cell dispersion. One individual treatment regimen includes 3 or more infusion bags for the total dose of 410 × 106 CD19 CAR-positive viable T cells. Each infusion bag is individually packed within an overwrap in a metal cassette. Metal cassettes are packed into a ModPak Modular Cryogenic Packout Kit. Up to 4 cassettes can fit in a single ModPak. Two ModPak may be required to transport the maximum number of 7 cassettes.
Autolus GmbH, Im Schwarzenbach 4, 79576 Weil am Rhein, Germany
EU/1/25/1951/001
| Drug | Countries | |
|---|---|---|
| AUCATZYL | Austria, Estonia, Lithuania, United States |
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