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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › OTHER ANTINEOPLASTIC AGENTS › Antineoplastic cell and gene therapy
tisagenlecleucel
L01XL04
Forms & Strengths
- Suspension for intravenous infusion: Patient-specific single-dose infusion bag containing a dispersion of autologous T cells transduced with a lentiviral vector expressing an anti-CD19 chimeric antigen receptor (CAR)
- Potency: 1.2 x 10^6 to 6 x 10^8 viable CAR-positive T cells
Adult Dosing
- Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Single intravenous infusion of 2.1 x 10^8 to 6 x 10^8 CAR-positive viable T cells
- Pre-treatment lymphodepleting chemotherapy: Fludarabine 25 mg/m^2 IV daily and cyclophosphamide 250 mg/m^2 IV daily for 3 days administered prior to infusion
Pediatric Dosing
- Relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) (patients up to 25 years of age): Single intravenous infusion of 0.2 x 10^8 to 5.0 x 10^8 CAR-positive viable T cells
- Pre-treatment lymphodepleting chemotherapy: Fludarabine 30 mg/m^2 IV daily for 4 days and cyclophosphamide 500 mg/m^2 IV daily for 2 days
Indications
- Treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse
- Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, including DLBCL not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma
Mechanism of Action
- Autologous T cells are genetically engineered with a lentiviral vector to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single-chain variable fragment (scFv) linked to 4-1BB (CD137) costimulatory and CD3-zeta signaling domains
- Binds to CD19-expressing B-cells, leading to activation of CAR-T cells, proliferation, and potent redirected cellular immune cytotoxicity against CD19-expressing malignant and normal cells
Contraindications
- Hypersensitivity to tisagenlecleucel or any component of the product formulation
- Live vaccines should not be given for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during tisagenlecleucel treatment, and until immune recovery following treatment
Adverse Reactions
- Cytokine Release Syndrome (CRS), which can be severe or fatal
- Immune effector cell-associated neurotoxicity syndrome (ICANS)
- Prolonged and recurrent cytopenias including neutropenia, thrombocytopenia, and anemia
- Serious infections and hypogammaglobulinemia
- Febrile neutropenia, hypotension, hypoxia, and tachycardia
Drug Interactions
- Avoid systemic corticosteroids or immunosuppressive agents prior to infusion except for lymphodepleting chemotherapy or management of severe CRS and neurotoxicity
- Live virus vaccines: Safety of immunization with live viral vaccines during or following tisagenlecleucel therapy has not been studied; vaccination with live vaccines is not recommended
Curated Content: Needs Vetting Before Put to Clinical Use