Gumiguru 2021: Brexucabtagene autoleucel (Tecartus, Kite Pharma, Inc.) has been approved by the Food and Drug Administration for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
In ZUMA-3 (NCT02614066), a single-arm multicenter trial in individuals with relapsed or refractory B-cell precursor ALL, the efficacy of brexucabtagene autoleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell treatment, was assessed. Following lymphodepleting chemotherapy, patients received a single infusion of brexucabtagene autoleucel.
Mhinduro yakakwana (CR) mukati memwedzi ye3 yekunyudzwa uye kusimba kweCR ndiyo yaive nzira yemhedzisiro yakashandiswa kutsigira kubvumidzwa. Mukati memwedzi mitatu, makumi maviri nemasere (28 muzana; 52 muzana CI: 95, 38) yevarwere makumi mashanu nevaviri vanogona kuongororwa kuti vabudirire vakawana CR. Nguva yepakati yeCR haina kusangana nekutevera kwepakati pemwedzi ye66 kune vanopindura; kureba kweCR kwaitarisirwa kudarika mwedzi ye54 kweanopfuura hafu yevarwere.
Yambiro yebhokisi ye cytokine release syndrome (CRS) and neurologic toxicities is included in the prescribing material for brexucabtagene autoleucel. In 92 percent of cases (Grade 3, 26 percent), CRS developed, and in 87 percent of cases (Grade 3, 35 percent), neurologic toxicities occurred. Fever, CRS, hypotension, encephalopathy, tachycardias, nausea, chills, headache, fatigue, febrile neutropenia, diarrhoea, musculoskeletal pain, hypoxia, rash, edoema, tremor, infection with an unspecified pathogen, constipation, decreased appetite, and vomiting were the most common non-laboratory adverse reactions (incidence 20%).
A single intravenous infusion of 1 x 106 CAR-positive viable T cells per kg body weight (maximum 1 x 108 CAR-positive viable T cells) is advised for brexucabtagene autoleucel treatment, followed by fludarabine and cyclophosphamide for lymphodepleting chemotherapy.
