2020 yil dekabr: The University of Texas MD Anderson Cancer Center researchers discovered that axi-cel, an autologous anti-CD19 chimeric antigen receptor (CAR) T cell therapy, is a safe and effective first-line therapy for patients with high-risk large B-cell lymphoma (LBCL), a group in desperate need of new and effective treatments.
Ushbu topilmalar Amerika Gematologiya Jamiyatining virtual 2020 yillik yillik yig'ilishida taqdim etildi.
Traditionally, around half of patients with high-risk LBCL, a subgroup of the disease in which patients have double- or triple-hit limfoma or additional clinical risk factors identified by the International Prognostic Index (IPI), have not achieved long-term disease remission with standard treatment approaches such as chemoimmunotherapy.
Bu sinov qilish sari qadamdir CAR T hujayra terapiyasi a first-line treatment option for patients with aggressive B-cell lymphoma,” said Sattva S. Neelapu, M.D., professor of Lymphoma and Myeloma. “At the moment, patients with newly diagnosed aggressive B-cell lymphoma get chemotherapy for about six months. CAR T hujayra terapiyasi, agar muvaffaqiyatli bo'lsa, uni bir oy ichida yakunlangan davolanish bilan bir martalik infuzion qilish mumkin.
ZUMA-1ning asosiy tadqiqotiga asoslanib, Axi-cel hozirda ikki yoki undan ortiq tizimli davolash kurslarini oʻtkazgan relapsli yoki refrakter LBCL bilan kasallangan odamlarni davolash uchun litsenziyalangan. ZUMA-12 sinovi 2-bosqich ochiq yorliqli, bir qoʻlli, koʻp markazli sinov boʻlib, ZUMA-1 sinovi natijalariga asoslanib, yuqori xavfli LBCL bilan ogʻrigan bemorlar uchun axi-celni birinchi darajali terapiya sifatida qoʻllashni baholashga qaratilgan. .
ZUMA-12 oraliq tadqiqotiga ko'ra, axi-cel bilan davolangan bemorlarning 85 foizi umumiy javobga ega bo'lgan va 74 foizi to'liq javob bergan. O'rtacha 9.3 oylik kuzatuvdan so'ng, ishga qabul qilingan bemorlarning 70 foizi ma'lumotlarning uzilishida davomiy javobni ko'rsatdi.
Oq qon hujayralari sonining kamayishi, ensefalopatiya, anemiya va sitokinlarni chiqarish sindromi axi-cel davolash bilan bog'liq eng keng tarqalgan yon ta'siri edi. Ma'lumotlar tahlil qilinganda, barcha noxush hodisalar bartaraf etilgan.
Bundan tashqari, immunoterapiya mahsulotlari bir necha qator kimyoterapiya olgan bemorlardan ishlab chiqarilgan vaqt bilan solishtirganda, qondagi CAR T hujayralarining eng yuqori darajasi, shuningdek, CAR T hujayralarining o'rtacha kengayishi ushbu sinovda yuqoriroq bo'lgan. birinchi qator CAR T hujayra terapiyasi.
"Ushbu T hujayrali fitnes terapevtik samaradorlik bilan bog'liq bo'lishi mumkin, bu esa bemorning yaxshi natijalariga olib kelishi mumkin", deya qo'shimcha qildi Nelapu.
ZUMA-12 ning ajoyib oraliq natijalaridan so'ng, tadqiqotchilar bemorlarning dori-darmonlarga bo'lgan reaktsiyalari uzoq davom etishini ta'minlash uchun ularni kuzatishni davom ettirishni rejalashtirmoqdalar.
“A randomised clinical trial would be required to definitely demonstrate that CAR T cell therapy is superior to existing standard of care with chemoimmunotherapy in these high-risk patients if the responses are persistent after prolonged follow-up,” Neelapu said. It also begs the question of whether CAR T cell treatment should be tested in intermediate-risk patients with big B-hujayra limfoma.
