2021 yil oktyabr: Brexucabtagene autoleucel (Tecartus, Kite Pharma, Inc.) Oziq-ovqat va farmatsevtika idorasi tomonidan relapsli yoki refrakter B hujayrali prekursorli kattalar bemorlari uchun tasdiqlangan o'tkir limfoblastik leykemiya (ALL).
ZUMA-3 (NCT02614066) da relapsli yoki refrakter B-hujayra prekursorlari bo'lgan shaxslarda bir qo'lli ko'p markazli sinov. BARCHA, CD19ga yo'naltirilgan kimerik antigen retseptorlari bo'lgan brexucabtagene autoleucelning samaradorligi (CAR) T-hujayralarini davolash, baholandi. Limfodepleating kimyoterapiyadan so'ng bemorlar brexucabtagene autoleucelning bir martalik infuzionini oldilar.
Infuziondan keyin 3 oy ichida to'liq javob (CR) va CRning chidamliligi tasdiqlashni qo'llab-quvvatlash uchun foydalanilgan samaradorlik natijasi mezonlari edi. Uch oy ichida samaradorlik uchun baholangan 28 bemordan 52 tasi (95 foiz; 38 foiz CI: 66, 54) CR ga erishdi. CRning o'rtacha davomiyligi javob beruvchilar uchun 7.1 oylik o'rtacha kuzatuv bilan uchrashmadi; Bemorlarning yarmidan ko'pi uchun CR davomiyligi 12 oydan oshib ketishi kutilgan edi.
uchun qutidagi ogohlantirish sitokinlarni chiqarish sindromi (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, Chr, 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.
