Mungkin 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.
Taun 2021, seueur usaha Koréa ngaluncat kana pamekaran terapi CAR-T. Insidén industri nyatakeun yén perusahaan biofarmaseutik lokal gumbira kalayan persetujuan lokal pikeun terapi CAR-T Novartis (bahan: tisagenlecleucel).
Ku ngawanohkeun reséptor antigén chimeric kana sél T immunological, terapi CAR-T mangrupakeun tipe terapi sél nu nargétkeun sél kanker. Kadang-kadang disebut "ubar antikanker mujijat" kusabab tingkat réspon anu luar biasa.
Produksina mangrupikeun prosés anu susah anu kalebet ngumpulkeun sél T pasien di rumah sakit sareng ngokolakeunana dina fasilitas anu nuturkeun prakték manufaktur anu saé (GMP).
CAR T-Cell prosés produksi jeung administrasi
Tisa-cel, hiji-hijina produk CAR T-sél anu dilisensikeun sacara komersil di Korea, mangrupikeun terapi sélulér anu dipersonalisasi sacara autologous anu peryogi operasi leukaferesis sateuacan sumbangan sél T ti pasien. Fabrikasi sél ieu salajengna dipercayakeun ka fasilitas manufaktur anu dilisensikeun (di belahan bumi sanés). Produk réngsé dikirim ka rumah sakit pikeun infus pasien saatos manufaktur sareng pamariksaan kualitas [2]. Pasén nyanghareupan halangan anu ageung kusabab téknik administrasi sareng kerumitan produksi sél T CAR. Slot produksi kawates tiasa nyegah palaksanaan prosés anu suksés sabab produksina gumantung pisan kana tenaga kerja pabrik, sedengkeun gangguan ranté suplai kadang nyababkeun telat anu teu disangka-sangka.
Henteuna fasilitas perawatan CAR T-sél akreditasi mangrupikeun masalah anu penting pikeun diakses pasien. Perawatan T-sél CAR parantos nyéépkeun seueur sumber sabab ngabutuhkeun sajumlah ageung profésional anu terampil sareng infrastruktur anu dipercaya [3]. Aya peryogi unit perawatan intensif, fasilitas leukaferesis, panyimpen sél anu cukup, unit klinis terstruktur sareng protokol anu ditetepkeun pikeun ngawas sareng ngatur pasien anu ngembang masalah akut, sareng unit klinis kalayan daérah kerja anu teratur. Hematologists, spesialis ubar perawatan kritis devoted, neurologists, sarta perawat dilatih terus diperlukeun dina hal staf médis. Kamentrian Kasalametan Pangan sareng Narkoba Korea ogé kedah ngevaluasi sadaya pusat anu ngarencanakeun pikeun nyayogikeun terapi sél T CAR saluyu sareng "kalakuan ngeunaan kasalametan sareng dukungan pikeun ubar regeneratif canggih sareng produk biologis canggih" sareng "keputusan penegak kalakuan dina. kasalametan sarta rojongan pikeun ubar regenerative canggih jeung produk biologis canggih "[4]. Hasilna, Seoul sacara fisik janten bumi pikeun seuseueurna fasilitas terapi sél-T CAR Korea, nambihan larangan anu parantos aya.
Biaya tinggi & produksi terapi T-Cell CAR di Korea
Biaya obat anu luhur anu dikembangkeun ku perusahaan farmasi multinasional ngajadikeun hésé pikeun pasien Korea ngaksés éta. Hasilna, usaha Korea nyiptakeun sareng ngalokalkeun pangobatan CAR-T dina usaha pikeun ngatasi masalah ieu. Seueur usaha anu parantos ngamimitian ngembangkeun terapi CAR-T atanapi nyatakeun niatna pikeun ngalakukeunana, kalebet Curocell, Abclon, GC Cell, Ticaros, Helixmith, Toolgen, Cllengene, Eutilex, sareng Vaxcell Bio.
Salaku perusahaan Korea munggaran anu ngamimitian uji klinis perawatan CAR-T di Koréa, Curocell nampi persetujuan ti Kamentrian Kaamanan Pangan sareng Narkoba dina bulan Pebruari pikeun uji klinis fase 1 CRC01, calon perawatan 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.
At101 mangrupikeun calon terapi CD19 CAR-T, sareng Abclon parantos ngalebetkeun aplikasi pangobatan anyar pikeun uji coba fase 1 dina Juni. Pasén anu kambuh atanapi tahan limfoma non-Hodgkin sél B mangrupikeun populasi target pikeun perusahaan.
Régulator henteu acan masihan korporasi, sanaos. GC Cell badé ngembangkeun perawatan CAR-T na di Amérika Serikat, teu sapertos Curocell sareng Abclon.
Ngaliwatan Novacel, éta maksudna pikeun ngalaksanakeun uji klinis pikeun terapi CAR-T khusus mesothelin. Salaku tambahan, perusahaan hoyong ngadamel kanker padet.
Rumah sakit universitas utama parantos ngamimitian nalungtik terapi CAR-T sareng siap-siap nyetél infrastruktur anu aya hubunganana, janten minat terapi CAR-T henteu dugi ka usaha.
Fasilitas perawatan sél CAR-T munggaran di nagara éta debut dina April di Pusat Médis Samsung. Rumah Sakit St. Mary di Seoul sareng Eutilex natan MOU dina bulan Séptémber pikeun gawé bareng ngembangkeun terapi 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.
