Kukadzi 2024: Kuedza kweChina kwekupayona mukugadzira budiriro yekurapa cancer kwakawana kusimba nekuunzwa kwechimeric antigen receptor (CAR) -engineered T-cell (CAR T) kurapwa kwe. akawanda myeloma, kenza yeropa inoparadza inoratidzwa nemasero eplasma asina kukwana. Iyi nzira itsva inomiririra nguva yemvura mumishonga yakasarudzika, ichipa tariro kune varwere vane dzimwe nzira dzanga dzave shoma kusvika zvino.
Mhedziso yeCAR-T Cell Therapy
CAR T-cell kurapa inoshandisa masero emurwere ekudzivirira emuviri kuona uye kunanga maseru egomarara anoratidza mapuroteni chaiwo. Injiniya aya T masero kuti abatanidze artificial receptors anozivikanwa seCARs anoashandura kuva zvombo zvakanangwa zvakanyanya zvinokwanisa kuparadza. tumarara masero. Kana mumwe munhu ane myeloma yakawanda, masero eCAR T anochinjwa kuti atarise BCMA, puroteni inowanikwa muhuwandu hwevarwere.
Clinical Miedzo uye Migumisiro
FUCASO
Muna 2018, IASO Biotherapeutics uye Innovent Biologics yakatanga multicenter Phase 1/2 tsvagiridzo yekuongorora. equecabtagene autoleucel (FUCASO), China yekutanga kugadzirwa mudzimba CAR T-cell kurapwa. Chidzidzo ichi chaisanganisira vanhu makumi manomwe nevapfumbamwe vane myeloma yakawanda vaive vapedza sarudzo dzekurapa. Sezvineiwo, iyo yakazara mhinduro mwero (ORR) yakawana 79%, nepo mhinduro yakakwana/yakaomarara mhinduro yakakwana (CR/sCR) chiyero yaive 94.9%. Nguva yepakati yekupora uye CR / sCR yaive mazuva gumi nematanhatu nemazuva makumi mapfumbamwe nemashanu, zvichiteerana. Izvi zvakawanikwa zvakasimbisa kushanda kwakanaka kwe equecabtagene autoleucel pamwe nekunaka kwayo kuchengetedza chimiro.
Kune varwere vakambove neCAR T-cell kurapwa, iyo ORR yakakwira kusvika 98.5%, nevatanhatu vachiwana CR/sCR. Sezvineiwo, murwere wekutanga akarapwa mukutongwa akachengetedza kuregererwa kuzere kwemwedzi inopfuura makumi mana.
CILTA-CEL kurapwa
Cilta-cel, inozivikanwawo se ciltacabtagene autoleucel, i-cut-edge chimeric antigen receptor (CAR) T-cell treatment iyo inotarisa B-cell maturation antigen (BCMA), puroteni inoratidzirwa mumasero akawanda emyeloma. Mushonga mutsva uyu wakaratidza chivimbiso chikuru mukurapa kudzokororwa uye refractory multiple myeloma, ichipa tariro itsva kuvarwere vakapedza nzira dzekurapa dzechivanhu.
Cilota-cel kurapwa inoshandura masero eT emurwere kuratidza maCAR anosunga kuBCMA pamasero emyeloma. Kana yangodzoserwa mumurwere, aya akachinjwa masero eCAR T anogona kubudirira kunanga nekuparadza maseru akaipa, zvichikonzera kudzoka kwebundu uye pamwe kuregererwa kwenguva refu.
Clinical efficacy
Miedzo yemakiriniki, kunyanya yakakosha MUKATI-1 muyedzo, vakaratidza kuti cilta-cel yaive nehunyanzvi hwekuita muvarwere vakanyanya kufanorapwa vane kudzokazve kana kuti refractory multiple myeloma. Mhedzisiro yemiedzo iyi yakaratidza kunoshamisa kwese kupindurwa mwero (ORR) ye98%, ine chikamu chakakosha chevarwere vanowana yakasimba mhinduro dzakakwana (sCR).
Pakutevera kwepakati kwemwedzi makumi maviri nemasere, cilta-cel yakaratidza mhinduro dzakasimba, nekupona kwepakati-pasina kusati kwasvika. Mushonga wacho wakaratidzawo maitiro ekuchengetedza ane musoro, ane zviitiko zvakashata zvinobudirira kubudirira kuburikidza nenzira dzinotsigira kuchengetedza.
Matambudziko nemikana
Pasinei nemigumisiro inovimbisa, matambudziko makuru achiripo. Zvizhinji kliniki miedzo muChina idiki-diki uye imwe-center, isina kusimba kwakakwana uye kurongeka pakati pemasangano. Kugadzirisa zvirambidzo izvi, mafemu anofanirwa kutora chikamu zvine hukasha mukushambadzira kweCAR T kurapwa, kuve nechokwadi chekuti inowanikwa kune varwere.
Uyezve, nzira dzakagadziridzwa dzekugadzira, nzira dzinokurumidza kudzora, uye kuwedzera kwekuwana kwevarwere kunodiwa kuti uve nechokwadi chekuti CAR T-cell kurapa inoshandurwa zvinobudirira kubva pabhenji rerabhoritari kuenda padivi pemubhedha. Kudyidzana pakati peacademia, indasitiri, uye masangano ehurumende kwakakosha pakufambisa hunyanzvi uye kuvandudza kutarisirwa kwevarwere.
Ndedzipi njodzi dzeCAR T-Cell kurapwa mune akawanda myeloma varwere?
Maside effects eCAR T-Cell therapy mumultiple myeloma akafanana neaya ari muleukemia uye lymphoma.
Cytokine Release Syndrome (CRS) chimwe chezvakanyanya kukonzerwa neCAR T-cell therapy, zvichikonzera zviratidzo zvakadai sefivha, kuderera kweropa, kunetseka kufema, kusvotwa, uye mapundu. Zviitiko zvizhinji zvakapfava, asi zvakakomba zvinogona kuisa upenyu panjodzi.
Neurological side effects, zvakadai sokuvhiringidzika, pfari, kana kuti kuoma kutaura nokunzwisisa, kunogona kuva kwakakomba uye kunoda kupindira kwokukurumidza kwokurapa.
Zvimwe Zvakakomba side-effects: Izvi zvinogona kusanganisira mhinduro dzeallergic panguva yekuiswa, kukanganiswa kwemasoja emuviri, izvo zvinowedzera mukana wekutapukirwa, kuderera kwemasero eropa, uye zvinogona kuitika kwenguva refu yetsinga dzetsinga.
Kupfupisa, nepo CAR T-cell therapy inopa mabhenefiti akakosha maererano nehuwandu hwekupindura uye kurapwa kwemunhu kune akawanda myeloma varwere, inotakurawo njodzi dzakadai se cytokine release syndrome uye neurological side effects, iyo inofanirwa kunyatsotariswa uye kutungamirwa nevarapi vehutano. . Vhara kutarisa mushure kurapa kunodiwa kuchengetedza kuchengetedzwa kwemurwere uye kugadzirisa kurapwa zvabuda.
Zvichaitika mune ramangwana
Sezvo China ichienderera mberi nekudyara zvakanyanya mukutsvagisa biomedical, munda weCAR T-cell kurapwa unotarisirwa kukura zvakanyanya. China National Medical Products Administration (NMPA) yakaziva vimbiso yeCAR T-sero kurapwa nekusarudza equecabtagene autoleucel senzira yekurapa yebudiriro uye mushonga wenherera. Kurudziro iyi inoratidza kuzvipira kwehurumende yeChina mukuvandudza budiriro yemishonga.
Zvakare, equecabtagene autoleucel iri kutariswa semushonga unogoneka weneuromyelitis optica spectrum chirwere. Izvi zvinoratidza kuti CAR T-cell therapy inogona kushandiswa kune zvimwe zvinhu kunze kwegomarara.
Nekuenderera mberi kwekudyara muzvivakwa, dzidzo, uye hukama hwekubatana, China yakanyatso kutungamira nzira mu CAR T-cell kurapa kune akawanda myeloma nezvimwe zvirwere zvinouraya.
Ndeupi mutengo weCAR T-Cell kurapwa kune akawanda myeloma muChina?
Mutengo we 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 CAR T-Cell kurapa kwekiriniki miedzo iyo inodhura pakati pe $ 60-80,000 USD.
