ፌብሩዋሪ 2024 China’s pioneering efforts in creating breakthrough cancer therapeutics have gained traction with the introduction of chimeric antigen receptor (CAR)-engineered T-cell (CAR T) therapy for በርካታ እቴሎማ, a devastating blood cancer characterized by aberrant plasma cells. This new method represents a watershed moment in customized medicine, providing hope to patients whose alternatives had hitherto been limited.
የCAR-T የሕዋስ ሕክምና አጠቃላይ እይታ
CAR ቲ-ሴል ሕክምና uses a patient’s own immune cells to identify and target cancer cells that express specific proteins. Engineering these T cells to incorporate artificial receptors known as CARs transforms them into highly targeted weapons capable of destroying እብጠት cells. When someone has multiple myeloma, CAR T cells are changed to target BCMA, a protein that is found in large amounts in patients.
ክሊኒካዊ ሙከራዎች እና ውጤቶች
FUCASO
In 2018, IASO Biotherapeutics and Innovent Biologics launched multicenter Phase 1/2 research to evaluate equecabtagene autoleucel (FUCASO), China’s first domestically made CAR T-cell treatment. The study included 79 individuals with multiple myeloma who had exhausted their standard therapy choices. Interestingly, the overall response rate (ORR) achieved 94.9%, while the complete response/stringent complete response (CR/sCR) rate was 58.2%. The median time to recovery and CR/sCR were 16 days and 95 days, respectively. These findings confirmed equecabtagene autoleucel’s outstanding efficacy as well as its excellent safety profile.
ከዚህ ቀደም የCAR ቲ-ሴል ህክምና ለነበራቸው ታካሚዎች፣ ORR ወደ 98.5% ከፍ ብሏል፣ ስድስት CR/sCR በማሳካት ላይ። በተለይም በሙከራው የታከመ የመጀመሪያው ታካሚ ከ 40 ወራት በላይ ሙሉ ስርየትን ጠብቋል።
CILTA-CEL ሕክምና
Cilta-cel, also known as ciltacabtagene autoleucel, is a cutting-edge chimeric antigen receptor (CAR) T-cell treatment that targets B-cell maturation antigen (BCMA), a protein that is overexpressed in multiple myeloma cells. This novel medicine has shown great promise in treating relapsed and refractory multiple myeloma, providing new hope to patients who have exhausted traditional treatment alternatives.
የCilota-cel ህክምና በታካሚው ቲ ህዋሶች ዘረመል ይለውጣል ከቢሲኤምኤ ጋር የተያያዙ ሚሎማ ሴሎችን ለመግለጽ። አንዴ ወደ በሽተኛው ከገቡ በኋላ እነዚህ የተቀየሩት የCAR ቲ ህዋሶች አደገኛ ህዋሶችን በተሳካ ሁኔታ ማነጣጠር እና ማጥፋት ይችላሉ፣ በዚህም ምክንያት የዕጢ ማገገም እና ምናልባትም የረጅም ጊዜ ስርየትን ያስከትላል።
ክሊኒካዊ ውጤታማነት
Clinical trials, notably the important CARTITUDE-1 trial, have shown that cilta-cel had outstanding efficacy in extensively pretreated patients with relapsed or refractory multiple myeloma. The results of these trials revealed a remarkable overall response rate (ORR) of 98%, with a significant proportion of patients achieving strict complete responses (sCR).
በ28 ወራት አማካኝ ክትትል፣ cilta-cel ቀጣይነት ያለው ምላሾችን አሳይቷል፣ ከመካከለኛው ግስጋሴ-ነጻ መትረፍ ገና ሊደረስበት አልቻለም። መድኃኒቱ ምክንያታዊ የሆኑ የደህንነት መገለጫዎችን አሳይቷል፣ አሉታዊ ክስተቶች በድጋፍ እንክብካቤ ዘዴዎች በተሳካ ሁኔታ ተካሂደዋል።
ተፈታታኝ ሁኔታዎች እና ዕድሎች ፡፡
Despite the promising results, significant challenges remain. Most ክሊኒካዊ ሙከራዎች in China are small-scale and single-center, with insufficient rigor and coordination among institutions. To address these restrictions, firms must aggressively participate in the commercialization of CAR T therapy, ensuring that it is widely available to patients.
Furthermore, improved manufacturing methods, faster regulatory channels, and increased patient access are required to ensure that CAR ቲ-ሴል ሕክምና is successfully translated from laboratory bench to bedside. Collaborations between academia, industry, and government agencies are critical for driving innovation and improving patient care.
በበርካታ myeloma በሽተኞች ውስጥ የ CAR ቲ-ሴል ሕክምና ምን አደጋዎች አሉት?
The side effects of CAR T-Cell therapy in multiple myeloma are similar to those in leukemia and ሊምፎማ.
ሳይቶኪን መልቀቂያ ሲንድሮም (CRS) እንደ ትኩሳት፣ ዝቅተኛ የደም ግፊት፣ የመተንፈስ ችግር፣ ማቅለሽለሽ እና ሽፍታ ያሉ ምልክቶችን የሚያስከትል የ CAR ቲ-ሴል ሕክምና በጣም ተስፋፍተው ከሚመጡት የጎንዮሽ ጉዳቶች አንዱ ነው። አብዛኛዎቹ ክስተቶች ቀላል ናቸው, ነገር ግን ከባድ የሆኑ ሁኔታዎች ለሕይወት አስጊ ናቸው.
የነርቭ የጎንዮሽ ጉዳቶችእንደ ግራ መጋባት፣ መናድ ወይም የመናገር እና የመረዳት ችግሮች ከባድ ሊሆኑ እና ፈጣን የሕክምና ጣልቃገብነት ያስፈልጋቸዋል።
ሌሎች ከባድ የጎንዮሽ ጉዳቶች: እነዚህ በመርፌ ጊዜ የአለርጂ ምላሾችን፣ የሰውነትን በሽታ የመከላከል ስርዓት የተዳከመ፣ ይህም የኢንፌክሽን አደጋን የሚጨምር፣ የደም ሴል ብዛት ዝቅተኛ እና የረጅም ጊዜ የነርቭ ሥርዓት መዘዝን ሊያጠቃልል ይችላል።
To summarize, while CAR T-cell therapy provides significant benefits in terms of high response rates and personalized treatment for multiple myeloma patients, it also carries risks such as cytokine release syndrome and neurological side effects, which must be carefully monitored and managed by healthcare providers. Close monitoring after therapy is required to maintain patient safety and optimize treatment ውጤቶች
የወደፊት ተስፋዎች
ቻይና በባዮሜዲካል ምርምር ላይ ሰፊ ኢንቨስት ማድረጉን ስትቀጥል፣የ CAR ቲ-ሴል ህክምና ዘርፍ በከፍተኛ ደረጃ እንደሚያድግ ይጠበቃል። የቻይና ብሄራዊ የህክምና ምርቶች አስተዳደር (NMPA) equecabtagene autoleucelን እንደ አንድ ግኝት ሕክምና እና ወላጅ አልባ መድኃኒት አድርጎ በመሾም የ CAR ቲ-ሴል ሕክምናን ቃል ገብቷል ። ይህ ድጋፍ የቻይና መንግስት ቆራጥ የሆኑ የህክምና እድገቶችን ለማዳበር ያለውን ቁርጠኝነት ያሳያል።
እንዲሁም፣ equecabtagene autoleucel ለኒውሮሚየላይትስ ኦፕቲካ ስፔክትረም ሕመም ሕክምና ሊሆን እንደሚችል እየታየ ነው። ይህ የሚያሳየው የ CAR ቲ-ሴል ህክምና ከካንሰር ውጪ ለሆኑ ነገሮች ጥቅም ላይ ሊውል ይችላል.
With continuous investment in infrastructure, education, and collaborative relationships, China is well-positioned to lead the way in CAR ቲ-ሴል ሕክምና for multiple myeloma and other life-threatening diseases.
በቻይና ውስጥ ለብዙ myeloma የ CAR T-cell ሕክምና ዋጋ ስንት ነው?
The cost of CAR T-Cell therapy for multiple myeloma depends upon the type of CAR T Cell therapy chosen and the hospital chosen. The cost of FUCASO treatment is around $ 200,000 USD in different hospitals. The cost of CILTA-CEL therapy also varies between $ 200-250,000 USD. However, patients can also opt for የ CAR ቲ-ሴል ሕክምና ክሊኒካዊ ሙከራዎች which will cost between $ 60-80,000 USD.
