ማርች 2022: ከአራት ወይም ከዚያ በላይ የቀደሙ የሕክምና መስመሮች፣ ፕሮቲአሶም አጋቾቹ (PI)፣ immunomodulatory agent (IMiD) እና ፀረ-CD38 ሞኖክሎናል ፀረ እንግዳ አካላትን ጨምሮ፣ የምግብ እና የመድኃኒት አስተዳደር ciltacabtagene autoleucelን አጽድቋል። (CARVYKTI፣ Janssen Biotech, Inc.) ለአዋቂ ታማሚዎች ለማገገም ወይም ለማገገም ብዙ myeloma.
Ciltacabtagene autoleucel የ B-cell maturation antigen (BCMA) ላይ ያነጣጠረ በዘረመል ምህንድስና የተፈጠረ አውቶሎጅ ቺሜሪክ አንቲጂን ተቀባይ CAR ቲ-ሴል ቴራፒ ሕክምና ነው። እያንዳንዱ መጠን ለታካሚው ቲ-ሴሎች የተዘጋጀ ነው, እነሱም ተሰብስበዋል, በጄኔቲክ ተሻሽለው እና ከዚያም እንደገና ወደ በሽተኛው ይተዋወቃሉ.
CARTITUDE-1 (NCT03548207) was an open label, multicenter ክሊኒካዊ ሙከራ that looked at the safety and efficacy of ciltacabtagene autoleucel in 97 patients with relapsed or refractory በርካታ እቴሎማ who had received at least three prior lines of therapy, including a PI, an IMiD, and an anti-CD38 monoclonal antibody, and who had disease progression on or after the last chemotherapy regimen Patients were given 0.51.0106 CAR-positive viable T cells per kg body weight of ciltacabtagene autoleucel. Efficacy was determined by an Independent Review committee utilising the International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma to assess overall response rate (ORR) and duration of response (DOR). The ORR was 97.9% (95 percent confidence interval: 92.7 percent, 99.7%). The median duration of response (DOR) was 21.8 months (95 percent CI: 21.8, NE) among the 95 patients who responded, with a median follow-up period of 18 months.
The CARVYKTI label includes a boxed warning for ሳይቶኪን መልቀቂያ ሲንድሮም (CRS), hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Parkinsonism and Guillain-Barré syndrome and their complications, and prolonged and/or recurrent cytopenia, which can all be fatal or life-threatening. Pyrexia, cytokine release syndrome, hypogammaglobulinemia, musculoskeletal pain, fatigue, infections, diarrhoea, nausea, encephalopathy, headache, coagulopathy, constipation, and vomiting were the most prevalent side effects of ciltacabtagene autoleucel.
CARVYKTI አደጋን የመገምገም እና የመቀነስ እቅድ አለው፣ ይህም ህክምናውን የሚያከፋፍሉ ሆስፒታሎች እና ክሊኒኮች በተለይ CRS እና የነርቭ ስርዓት መርዞችን ለመለየት እና ለመፍታት የምስክር ወረቀት እንዲሰጣቸው ይፈልጋል። ኤፍዲኤ ኩባንያው የረጅም ጊዜ ደህንነትን ለመገምገም በ ciltacabtagene autoleucel የታከሙ ታካሚዎችን ያካተተ የድህረ-ገበያ ምልከታ ጥናት እንዲያካሂድ እየጠየቀ ነው።
CARVYKTI በ 0.5-1.0106 CAR-positive አዋጭ ቲ-ሴሎች በኪሎ ግራም የሰውነት ክብደት ይሰጣል፣በአንድ መርፌ ከፍተኛው መጠን 1108 CAR-positive ቲ-ሴሎች።
