Isigulana esinesifo somhlaza wobuchopho esingapheliyo, esasiphinde sabuyela umva emva konyango lwe-CAR-T izihlandlo ezili-17, sabona ithumba laso linyamalala ngokupheleleyo kwiiveki ezi-4 emva kokufumana unyango olutsha lwe-TIL kwaye sihlale singenalo ithumba kangangeenyanga ezingaphezu kwama-20.
Ukuba unemibuzo malunga nonyango olutsha lomhlaza kunye novavanyo lweklinikhi:
Ifowuni: 4008803716 | WeChat: 17801183037| Email ：100085_010@163.com
Isigulana esiyindoda esineminyaka engama-56 ubudala sifunyenwe sine-glioblastoma ye-left frontal lobe (IDH wild-type, i-WHO Grade 4, i-EGFR amplification)—enye yeentlobo ze-brain glioma ezinobungozi nezinzima ukuzinyanga.
Emva kokuhlinzwa kwethumba ngoJanuwari 5, 2023, ekuqaleni wafumana unyango oluqhelekileyo, kodwa imeko yakhe yaphinda yabuya emva kwexesha elifutshane lokuzinza. Emva koko, wafumana unyango lwe-CAR-T olupheleleyo olujolise kwii-antigens ezimbini ezahlukeneyo, kodwa isifo sakhe saqhubeka nokuqhubeka.
Ephelelwe lithemba, wabhalisela uvavanyo lweklinikhi lonyango olutsha lwe-TIL. Iziphumo zazimangalisa: kwiiveki ezi-4 emva kokufakwa kweseli ye-TIL, uhlolo lwemifanekiso lubonisa ukuba ithumba ebuchotsheni bakhe lisusiwe ngokupheleleyo, nto leyo eyabangela impendulo epheleleyo, kwaye uhlale engenalo ithumba kangangeenyanga ezingaphezu kwama-20.
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Ukulwela Ukusinda Kwimeko Enzima
I-Glioblastoma yaziwa ngokuba “ngumbulali oyintloko ngaphakathi kwentloko.” Ixesha lokuxilongwa lifana nokuqala kokubala ubomi.
Emva kokufunyaniswa kukaMnu. W, waqala ngokususwa umhlaza wobuchopho onobungozi obukhulu, kwalandela i-temozolomide chemotherapy kunye ne-radiotherapy. Nangona kunjalo, imeko yakhe ayizange ilawulwe.
Emva koko, wazama iindlela ezimbini ezahlukeneyo zonyango lwe-CAR-T ezijolise kwii-antigens ezahlukeneyo, wafumana iinaliti ezingaphezu kwe-10 ngaphakathi kwethumba zizonke, kodwa oku akuzange kukwazi ukuthintela ukuqhubeka kwethumba.
Unyango lwesintu alusebenzi kakuhle kakhulu kwi-brain glioma ephucukileyo. Nokuba kukho izicwangciso zonyango ezidibeneyo ezibandakanya utyando, unyango ngemitha, kunye ne-chemotherapy, umlinganiselo wokuphila jikelele kwezigulane umalunga neenyanga ezili-14.6 kuphela.
Bejongene nemeko enjalo engenathemba, uMnu. W kunye nosapho lwakhe baziva bephelelwe lithemba kakhulu de bafunda ngovavanyo lweklinikhi lonyango lwe-TIL.
Unyango lwe-TIL
Unyango lwe-TIL, okanye unyango lwe-Tumor-Infiltrating Lymphocyte, lunyango olutsha lwe-immunotherapy lweseli.
Olu nyango luqala ngezicubu zethumba ezintsha zesigulana njengezinto ezisetyenzisiweyo. Emva kokuzahlula, ukutshintshwa, kunye nokwandiswa kwi-vitro, iiseli zibuyiselwa kwisigulana, zifumane unyango oluchanekileyo "olulwa nethumba ngokwalo."
Ngokungafaniyo nonyango lwe-CAR-T lwendabuko, unyango lwe-GC101 TIL alufuni i-lymphodepletion okanye i-IL-2 injections, nto leyo ephucula kakhulu ukhuseleko kunye nokulula konyango.
Iphuhliswe yiJuncell Therapeutics, unyango lwe-GC101 TIL lolona nyango lokuqala lwendalo lwe-TIL kwihlabathi lonke olungafuni i-lymphodepletion okanye i-IL-2 injection, isebenzisa iqonga layo lokukhulisa iiseli ze-DeepTIL® eliziphuhlisileyo.
Idatha yeklinikhi ekhoyo ibonisa ukuba i-GC101 inezinga lokuphendula elichanekileyo elidlula i-35% xa kuthelekiswa neentlobo ezahlukeneyo zeethumba eziqinileyo eziphucukileyo. Izigulane ezininzi zifikelele ekuphelisweni ngokupheleleyo kwethumba kunye nokusabela ngokupheleleyo, kwaye ixesha elide lokusinda ngaphandle kwethumba lidlula iminyaka emi-3.
Inkqubo Yonyango
Ngasekupheleni kuka-2023, uMnu. W wabhalisa ngempumelelo kuvavanyo lweklinikhi lonyango lwe-GC101 TIL.
Iqela lezonyango lisebenzise iiseli ze-TIL ezazikhuliswe kwisampulu yakhe yotyando ayifumene kunyaka ophelileyo, ezazigcinwe zikrwitshiwe de kwayimfuneko.
Iqela lonyango landise ngempumelelo iiseli ukuya kuthi ga kwi-2.95 × 10^10 TIL cells, ii-T-cells zibalwa kwi-99.92% yabemi, uninzi lwazo zii-CD8⁺ T-cells (97.85%).
Emva kokulungiswa kwangaphambili, uMnu. W wafumana i-TIL cell infusion ngoDisemba 12, 2023.
Ngexesha lokufakwa kweyeza, uMnu. W akazange afumane mpendulo ziqatha, kodwa ngumkhuhlane omncinci owaphela ngokukhawuleza. Xa kuthelekiswa nonyango lwe-TIL lwendabuko, olu hlobo luhlengahlengisiweyo lubonise ukhuseleko oluphezulu.
Ukuguquka Okumangalisayo
Kwiiveki ezi-4 nje emva kokufakwa kweseli ye-TIL, uvavanyo lwemifanekiso ngoJanuwari 8, 2024, lwatyhila ukuba ithumba ebuchotsheni bukaMnu. W lisusiwe ngokupheleleyo.
Okumangalisayo nangakumbi kukuba, ukusukela ngo-Okthobha ka-2025, isigulana besiphila ubomi obungenasimila kangangeminyaka engaphezu kwe-1.8 (kubalwa ngexesha lokukhutshwa kweendaba, oku kungaphezulu kweenyanga ezingama-20), sibuyela ebomini obuqhelekileyo.
Eli tyala libeka irekhodi entsha yokusinda kwi-glioblastoma ephindaphindayo kwaye libonelela ngobungqina obubalulekileyo bezonyango kwisicwangciso sonyango "sokuthatha iisampulu zezicubu kwangethuba, ukuphinda kufakwe i-TIL xa kubuya kwakhona."
Le mpumelelo imangalisayo iza kuboniswa kwipowusta kwiNtlanganiso yoNyaka yama-40 yeSociety for Immunotherapy of Cancer, eza kubanjwa ukususela nge-7-9 kaNovemba ngo-2025, iboniswa kwiingcali zoshishino zehlabathi.
Amathemba Exesha Elizayo
Unyango lwe-TIL lubonakalise amandla kungekuphela nje kunyango lwe-glioma yobuchopho kodwa lukwabonise ukusebenza okumangalisayo nxamnye nezinye iithumba eziqinileyo ezifana ne-melanoma ephucukileyo kunye nomhlaza wemiphunga ongengoweeseli ezincinci.
NgoFebruwari 2024, unyango lokuqala lwe-TIL cell therapy kwihlabathi, iLifileucel, lwafumana imvume ye-FDA e-United States yokunyanga izigulana ezine-melanoma ephucukileyo ezazifumene unyango lwe-PD-1 inhibitor ngaphambili.
Kwangaxeshanye, iTshayina iqhubela phambili uphando lwezonyango malunga nonyango lwe-TIL. Uvavanyo olubalulekileyo lweSigaba sesiBini lokubhalisa unyango lwe-Juncell Therapeutics's GC101 TIL injection olujolise kwi-advanced melanoma luvunyiwe yiZiko loVavanyo lwaMayeza le-National Medical Products Administration.
Ngaphezu koko, nge-14 ka-Okthobha ngo-2024, uvavanyo lokuqala lokubhaliswa kwamayeza e-TIL cell eTshayina ngokukodwa umhlaza wemiphunga lwaqaliswa ngokusesikweni, olujoliswe ekunyangeni umhlaza wemiphunga ongengoweeseli ezincinci osele uphucukile.
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Okwangoku, kusekho uvavanyo oluninzi lwezonyango lwamayeza amatsha okulwa nomhlaza kunye nobuchwepheshe eTshayina obufuna izigulane.
ISebe leMicimbi yeHlabathi leSibhedlele i-Oncology saseBeijing South Region libonelela ngeengcebiso ngamayeza amatsha kunye nobuchwepheshe.
Inombolo yefowuni: 4008803716
I-ID ye-WeChat: 17801183037
Email ①: 100085_010@163.com
Email ②: myimmnet@163.com
Ixesha lokuthumela: Novemba-20-2025