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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › OTHER ANTINEOPLASTIC AGENTS › Antineoplastic cell and gene therapy
lisocabtagene maraleucel
L01XL08
Forms & Strengths
- Suspension for intravenous infusion: 0.4 to 2.6 x 10^7 CAR-positive viable T cells in one to four single-dose vials
Adult Dosing
- Relapsed or refractory large B-cell lymphoma: Lymphodepleting chemotherapy with fludarabine (30 mg/m^2/day) and cyclophosphamide (300 mg/m^2/day) for 3 days, followed by single infusion of 50 to 110 x 10^6 CAR-positive T cells 2 to 7 days later
- Relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma: Lymphodepleting chemotherapy followed by a single infusion of 100 x 10^6 CAR-positive T cells
Pediatric Dosing
- Safety and efficacy not established in pediatric patients
Indications
- Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy
- Relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior lines including a BTK inhibitor and a BCL-2 inhibitor
Mechanism of Action
- Autologous CD19-directed genetically modified T cell immunotherapy that binds to CD19-expressing cancer and normal B cells, inducing T-cell activation, proliferation, and elimination of target cells
Contraindications
- Hypersensitivity to lisocabtagene maraleucel or any component of the product formulation
- Active systemic infection or inflammatory disorders
Adverse Reactions
- Cytokine release syndrome
- Neurological toxicities (ICANS)
- Prolonged cytopenias
- Serious infections
- Hypogammaglobulinemia
Drug Interactions
- Live vaccines: Do not administer live virus vaccines within 6 weeks prior to lymphodepleting chemotherapy, during CAR-T treatment, and until immune recovery
- Immunosuppressive agents: May impact the expansion and persistence of lisocabtagene maraleucel
Curated Content: Needs Vetting Before Put to Clinical Use