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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › OTHER ANTINEOPLASTIC AGENTS › Antineoplastic cell and gene therapy
brexucabtagene autoleucel
L01XL06
Forms & Strengths
- Suspension for intravenous infusion: 0.4 to 2 × 10^6 chimeric antigen receptor (CAR)-positive viable T cells per mL
- Individual patient-specific single-dose infusion bag containing a nominal dose of 2 × 10^8 autologous CAR-positive viable T cells
Adult Dosing
- Relapsed or refractory mantle cell lymphoma (MCL): Lymphodepleting chemotherapy with cyclophosphamide (500 mg/m² IV) and fludarabine (30 mg/m²) on days -5, -4, and -3, followed by single infusion of brexucabtagene autoleucel at a target dose of 2 × 10^8 CAR-positive viable T cells on day 0.
- Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL): Lymphodepleting chemotherapy with cyclophosphamide (750 mg/m² IV) on day -5 and fludarabine (25 mg/m²) on days -5, -4, and -3, followed by single infusion of 1 × 10^8 CAR-positive viable T cells on day 0.
Pediatric Dosing
- Safety and efficacy have not been established in pediatric patients with mantle cell lymphoma.
- Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (patients 18 years and younger): Same lymphodepleting and weight-based or fixed dosing regimen as adults, dependent on specific clinical trial criteria and institutional protocols.
Indications
- Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)
- Treatment of adult and pediatric patients 18 years of age and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Mechanism of Action
- Autologous T cell immunotherapy directed against CD19 antigen expressed on the surface of B-cells
- T cells are genetically modified ex vivo to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single-chain variable fragment (scFv), a CD28 costimulatory domain, and a CD3-zeta signaling domain
- Binding of the CAR to CD19 on target tumor cells induces T-cell activation, proliferation, and targeted elimination of CD19-expressing cells
Contraindications
- Hypersensitivity to any component of brexucabtagene autoleucel or its excipients (including dimethyl sulfoxide, DMSO)
- Active systemic infections or severe inflammatory disorders prior to infusion
Adverse Reactions
- Cytokine Release Syndrome (CRS)
- Immune effector cell-associated neurotoxicity syndrome (ICANS)
- Prolonged and severe cytopenias (thrombocytopenia, neutropenia, anemia)
- Serious infections (bacterial, viral, and fungal)
- Hypogammaglobulinemia
- Febrile neutropenia
- Fatigue, hypotension, tachycardia, and hypoxia
Drug Interactions
- Live vaccines: Do not administer live vaccines within 6 weeks prior to lymphodepleting chemotherapy, during brexucabtagene autoleucel treatment, and until immune recovery following treatment
- Corticosteroids: Systemic corticosteroids or immunosuppressive drugs may interfere with the activity of brexucabtagene autoleucel and should be avoided prior to infusion unless medically necessary for life-threatening conditions
Curated Content: Needs Vetting Before Put to Clinical Use