Kwangathi i-2023: Chimeric antigen receptor (CAR) T-cell therapy is an innovative development in the field of individualized cancer therapy. The patient’s own T-cells are genetically modified during the manufacturing process to express a synthetic receptor that binds to a tumour antigen. The patient’s body is then infused with CAR T-cells that have been grown for clinical usage and are ready to fight cancer cells. Even though CAR T-cell therapy is regarded as a significant advancement in cancer immunotherapy, it is not without drawbacks.
Chimeric antigen receptor T-cell (CAR T-cell) therapy is a ground-breaking component in the treatment of hematologic malignancies. Six CAR T-cell therapies have currently been approved by the US Food and Drug Administration (US FDA) (axicabtagene ciloleucel, brexucabtagene autoleucel, idecabtagene vicleucel, lisocabtagene maraleucel, tisagenlecleucel, and ciltacabtagene autoleucel), but only one (tisa-cel) is offered in Korea. In this study, we talk about the difficulties and obstacles that CAR T-cell treatment is now facing in Korea, such as the difficulties with patient accessibility, cost, and reimbursement.
Ngo-2021, amabhizinisi amaningi ase-Korea agxumela ekuthuthukisweni kwezindlela zokwelapha ze-CAR-T. Abangaphakathi embonini bathi izinkampani zendawo ze-biopharmaceutical zijabule ngokugunyazwa kwasendaweni kokwelashwa kwe-Novartis' CAR-T (isithako: tisagenlecleucel).
Ngokwethula ama-chimeric antigen receptors kuma-T cell amasosha omzimba, ukwelashwa kwe-CAR-T kuwuhlobo lokwelapha ngamaseli oluqondise kumaseli omdlavuza. Ngezinye izikhathi ibizwa ngokuthi “isidakamizwa esilwa nomdlavuza esiyisimangaliso” ngenxa yesilinganiso saso sokuphendula esimangalisayo.
Ukukhiqizwa kwayo kuyinqubo ekhandlayo ehlanganisa ukuqoqa ama-T cell esiguli esibhedlela futhi awatshale endaweni elandela imikhuba emihle yokukhiqiza (GMP).
Ukukhiqizwa kwe-CAR T-Cell kanye nenqubo yokuphatha
I-Tisa-cel, okuwukuphela komkhiqizo onelayisensi yokuthengisa ye-CAR T-cell e-Korea, iwukwelashwa kweselula komuntu siqu okuzenzakalelayo okudinga ukusebenza kwe-leukapheresis ngaphambi komnikelo we-T-cell ovela esigulini. Ukwenziwa kwalawa maseli kunikezwa izikhungo zokukhiqiza ezinelayisense (kweminye i-hemispheres). Imikhiqizo eqediwe ithunyelwa ezibhedlela ukuze ifakwe isiguli kulandela ukukhiqizwa kanye nokuhlolwa kwekhwalithi [2]. Iziguli zibhekene nesithiyo esikhulu ngenxa yesu lokuphatha kanye nobunkimbinkimbi bokukhiqizwa kwamaseli e-CAR T. Izikhala zokukhiqiza ezinomkhawulo zingavimbela ukwenziwa kwezinqubo ezilandelanayo njengoba ukukhiqizwa kuncike kakhulu kubasebenzi babakhiqizi, kuyilapho ukuphazamiseka kochungechunge lokunikezela ngezinye izikhathi kubangela ukubambezeleka okungalindelekile.
Ukungabikho kwezindawo zokwelashwa ezigunyaziwe ze-CAR T-cell kusengenye inkinga ebalulekile ngokufinyeleleka kwesiguli. Ukwelashwa kwe-CAR T-cell kakade kudla izinsiza eziningi ngoba kudinga inani elikhulu lochwepheshe abanamakhono aphezulu nengqalasizinda ethembekile [3]. Kunesidingo segumbi labagula kakhulu, isikhungo se-leukapheresis, indawo yokugcina amangqamuzana eyanele, indawo yomtholampilo ehlelekile enemigomo ebekiwe yokuqapha nokulawula iziguli eziba nezinkinga ezinkulu, kanye nophiko lwezokwelapha olunezindawo zokusebenza ezihlelwe kahle. Odokotela begazi, ochwepheshe bezokwelapha abazinikele, odokotela bezinzwa, nabahlengikazi abaqeqeshiwe bahlala bedingeka ngokwemibandela yabasebenzi bezokwelapha. UMnyango Wezokudla Nezidakamizwa Wase-Korea kufanele futhi uhlole zonke izikhungo ezihlela ukuhlinzeka ngokwelashwa kwe-CAR T-cell ngokuvumelana "nesenzo sokuphepha nokusekelwa kwemithi evuselelayo ethuthukisiwe kanye nemikhiqizo yebhayoloji ethuthukisiwe" kanye "nomthetho wokuphoqelela wesenzo ukuphepha nokusekelwa kwemithi ethuthukisiwe evuselelayo kanye nemikhiqizo ethuthukisiwe ye-biologic” [4]. Ngenxa yalokho, iSeoul iyikhaya ngokoqobo lezindawo eziningi zokwelapha i-CAR T-cell yaseKorea, okungeza emikhawulweni ekhona kakade.
Izindleko eziphezulu kanye nokukhiqizwa kwe-CAR T-Cell therapy eKorea
Izindleko eziphezulu zomuthi owenziwe izinkampani zamazwe ngamazwe ezithaka imithi zenza kube nzima ngeziguli zaseKorea ukuthi ziwufinyelele. Ngenxa yalokho, amabhizinisi ase-Korea adale futhi enza ukwelashwa kwe-CAR-T kwasendaweni ngomzamo wokubhekana nalezi zinkinga. Amabhizinisi amaningi aseqalile ukwenza izindlela zokwelapha ze-CAR-T noma amemezele inhloso yawo yokwenza kanjalo, okuhlanganisa i-Curocell, i-Abclon, i-GC Cell, i-Ticaros, i-Helixmith, i-Toolgen, i-Cllengene, i-Eutilex, ne-Vaxcell Bio.
Njengenkampani yokuqala yase-Korea eyaqala ukuhlolwa kokwelashwa kwe-CAR-T e-Korea, i-Curocell yathola imvume evela kuMnyango Wezokudla Nezokuphepha Kwezidakamizwa ngo-February yokuhlolwa komtholampilo kwesigaba 1 se-CRC01, ikhandidethi yokwelashwa kwe-CAR-T.
The company has used its unique technology known as “overcome immune suppression” to develop CRC01, a CD19 CAR-T therapy that inhibits the expression of immune checkpoint receptors, PD-1 and TIGIT.
Following the recruitment of patients with diffuse large B-cell lymphoma who had relapsed or been refractory after two or more rounds of systemic chemotherapy, the company is currently carrying out the trials at Samsung Medical Centre. The company Curocell, which started the treatment in April, recently stoked anticipation by releasing the preliminary findings of its phase 1 lowest dose cohort data.
I-At101 iyikhandidethi lokwelapha nge-CD19 CAR-T, futhi u-Abclon wayefake isicelo sakhe somuthi esisha esiphenywayo sovivinyo lwesigaba 1 ngoJuni. Iziguli ezine-B-cell non-Hodgkin's lymphoma ebuyele emuva noma ekwazi ukumelana nazo ziyisibalo sabantu okuqondiswe kuso inkampani.
Nokho, abalawuli abakayiniki inkampani ithuba. I-GC Cell ihlose ukuthuthukisa ukwelashwa kwayo kwe-CAR-T e-United States, ngokungafani ne-Curocell ne-Abclon.
Nge-Novacel, ihlose ukwenza isilingo somtholampilo sokwelashwa okuqondile kwe-CAR-T ye-mesothelin. Ukwengeza, inkampani ifuna ukuphatha umdlavuza oqinile.
Izibhedlela ezinkulu zamanyuvesi seziqalile ukucwaninga ngemithi yokwelapha ye-CAR-T futhi zilungiselela ukumisa izingqalasizinda ezihlobene, ngakho intshisekelo ekwelashweni kwe-CAR-T ayigcini emabhizinisini.
Isikhungo sokuqala sokwelapha amaseli e-CAR-T esizweni saqala ukusebenza ngo-Ephreli e-Samsung Medical Centre. Isibhedlela i-Seoul St. Mary's kanye ne-Eutilex bafake i-MOU ngo-September ukuze basebenzisane ukuthuthukisa ukwelashwa kwe-CAR-T.
Additionally, earlier this month the Ministry of Food and Drug Safety and the Ministry of Health and Welfare gave Seoul National University Hospital their blessing for a clinical trial of CAR-T therapy for paediatric patients with relapsed/refractory acute lymphoblastic leukaemia.
