Febhuwari 2024: Imizamo yaseShayina yokusungula izindlela zokwelapha umdlavuza isizuze amandla ngokwethulwa kwe-chimeric antigen receptor (CAR)-engineered T-cell (CAR T) therapy i-myeloma eminingi, umdlavuza wegazi obhubhisayo obonakala ngamangqamuzana e-plasma ashintshashintshayo. Le ndlela entsha imele umzuzu wokuchitheka kwamanzi emithini eyenziwe ngokwezifiso, enikeza ithemba ezigulini ebezinokunqunyelwa izindlela zazo kuze kube manje.
Uhlolojikelele lwe-CAR-T Cell Therapy
Ukwelashwa kwe-CAR T-cell 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 isisu cells. When someone has multiple myeloma, CAR T cells are changed to target BCMA, a protein that is found in large amounts in patients.
Izilingo Zomtholampilo Nemiphumela
I-FUCASO
Ngo-2018, i-IASO Biotherapeutics kanye ne-Innovent Biologics yethula ucwaningo lweSigaba 1/2 se-multicenter ukuze luhlole. I-equecabtagene autoleucel (FUCASO), Ukwelashwa kokuqala kwe-CAR T-cell okwenziwe ekhaya eChina. Ucwaningo lwaluhlanganisa abantu abangu-79 abane-myeloma eminingi ababesebenzise ukukhetha kwabo okujwayelekile kokwelashwa. Kuyathakazelisa ukuthi izinga lokuphendula lilonke (i-ORR) lifinyelele ku-94.9%, kuyilapho izinga lokuphendula eliphelele/eliqinile (CR/sCR) lalingu-58.2%. Isikhathi esimaphakathi sokululama kanye ne-CR/sCR kwakuyizinsuku eziyi-16 nezinsuku ezingama-95, ngokulandelana. Lokhu okutholakele kuqinisekise ukusebenza kahle okuvelele kwe-equecabtagene autoleucel kanye nephrofayili yayo yokuphepha enhle kakhulu.
Ezigulini ezake zithole ukwelashwa kwe-CAR T-cell, i-ORR ikhuphuke yafinyelela ku-98.5%, kwathi abayisithupha bazuza i-CR/sCR. Ngokuphawulekayo, isiguli sokuqala eselashwa ovivinyweni lwagcina ukuthethelelwa okugcwele okuqinile isikhathi esingaphezu kwezinyanga ezingama-40.
Ukwelashwa kwe-CILTA-CEL
I-Cilta-cel, eyaziwa nangokuthi yi-ciltacabtagene autoleucel, i-Cutting-Edge chimeric antigen receptor (CAR) T-cell treatment eqondise i-B-cell maturation antigen (BCMA), iphrotheni evezwe ngokweqile kumaseli amaningi e-myeloma. Lo muthi wenoveli ubonise isithembiso esikhulu ekwelapheni i-myeloma eminingi ebuyele emuva futhi ehlanekezelwe, enikeza ithemba elisha ezigulini esezisebenzise ezinye izindlela zokwelapha zendabuko.
Ukwelashwa kwe-Cilota-cel kuguqula ngofuzo amaseli e-T esiguli ukuze aveze ama-CAR abophezela ku-BCMA kumaseli e-myeloma. Uma esebuyiselwe esigulini, lawa maseli e-CAR T ashintshiwe angakhomba ngempumelelo futhi abhubhise amangqamuzana ayingozi, okuholela ekuhlehleni kwesimila futhi ngokunokwenzeka nokukhululwa kwesikhathi eside.
Ukusebenza komtholampilo
Izivivinyo zomtholampilo, ikakhulukazi ezibalulekile I-CARTITUDE-1 Ucwaningo, lubonise ukuthi i-cilta-cel isebenze kahle ezigulini ezelashwe kakhulu ezine-myeloma eminingi ebuyele emuva noma ephikisayo. Imiphumela yalezi zivivinyo yembula izinga lokuphendula eliphelele elimangalisayo (ORR) lama-98%, nengxenye ebalulekile yeziguli ezithola izimpendulo eziqinile eziphelele (sCR).
Ekulandeleni okumaphakathi kwezinyanga ezingama-28, i-cilta-cel ibonise izimpendulo eziqhubekayo, nokusinda okumaphakathi kokungena okuqhubekayo okusazofinyelelwa. Umuthi uphinde wabonisa amaphrofayili okuphepha anengqondo, nezenzakalo ezimbi ezilawulwa ngempumelelo ngezindlela zokunakekela ezisekelayo.
Izinselelo Namathuba
Despite the promising results, significant challenges remain. Most izivivinyo zokwelashwa 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 Ukwelashwa kwe-CAR T-cell is successfully translated from laboratory bench to bedside. Collaborations between academia, industry, and government agencies are critical for driving innovation and improving patient care.
Yiziphi izingozi zokwelashwa kwe-CAR T-Cell ezigulini eziningi ze-myeloma?
The side effects of CAR T-Cell therapy in multiple myeloma are similar to those in leukemia and i-lymphoma.
I-Cytokine Release Syndrome (CRS) ingenye yemiphumela emibi evame kakhulu yokwelashwa kwe-CAR T-cell, okubangela izimpawu ezinjengomkhuhlane, umfutho wegazi ophansi, ukuphefumula kanzima, isicanucanu, nokuqubuka. Izehlakalo eziningi zithambile, kodwa ezinzima zingabeka impilo engozini.
Imiphumela emibi ye-Neurological, njengokudideka, isithuthwane, noma ubunzima bokukhuluma nokuqonda, kungaba kubi kakhulu futhi kudinga ukungenelela kwezokwelapha ngokushesha.
Eminye imiphumela emibi kakhulu: Lokhu kungase kuhlanganise ukungezwani komzimba ngesikhathi sokumnika, isimiso somzimba sokuzivikela ezifweni esisengozini, okwandisa ingozi yokutheleleka, isibalo esiphansi samangqamuzana egazi, kanye nemiphumela yesikhathi eside yesistimu yezinzwa.
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 imiphumela.
Amathemba Esizayo
Njengoba i-China iqhubeka nokutshala imali kakhulu ocwaningweni lwe-biomedical, umkhakha wokwelashwa kwe-CAR T-cell kulindeleke ukuthi ukhule ngendlela emangalisayo. I-China National Medical Products Administration (NMPA) ibone isithembiso sokwelashwa kwe-CAR T-cell ngokuqoka i-equecabtagene autoleucel njengokubili ukwelapha okuphumelelayo kanye nomuthi wezintandane. Lokhu kugunyaza kukhombisa ukuzinikela kukahulumeni waseShayina ekwenzeni intuthuko esezingeni eliphezulu kwezokwelapha.
Futhi, i-equecabtagene autoleucel ibhekwa njengokwelashwa okungenzeka kwe-neuromyelitis optica spectrum disease. Lokhu kukhombisa ukuthi i-CAR T-cell therapy ingasetshenziselwa ezinye izinto ngaphandle komdlavuza.
With continuous investment in infrastructure, education, and collaborative relationships, China is well-positioned to lead the way in Ukwelashwa kwe-CAR T-cell for multiple myeloma and other life-threatening diseases.
Ziyini izindleko zokwelashwa kwe-CAR T-Cell ye-myeloma eminingi e-China?
Izindleko 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 Izivivinyo zomtholampilo zokwelashwa kwe-CAR T-Cell okuzobiza phakathi kuka-$60-80,000 USD.
