Isiguli esinesifo somdlavuza wobuchopho esibulalayo, esasiphinde sabuyela emuva ngemva kokwelashwa kwe-CAR-T izikhathi ezingu-17, sabona isimila saso sinyamalala ngokuphelele zingakapheli amasonto amane sithole ukwelashwa okusha kwe-TIL futhi sihlale singenaso isimila izinyanga ezingaphezu kuka-20.
Ukuze uthole imibuzo mayelana nokwelashwa okusha komdlavuza kanye nezivivinyo zemitholampilo:
Ucingo: 4008803716 | WeChat: 17801183037| Email ：100085_010@163.com
Isiguli sesilisa esineminyaka engu-56 ubudala sitholakale sine-glioblastoma yesobunxele engaphambili (i-IDH wild-type, i-WHO Grade 4, i-EGFR amplification)—esinye sezinhlobo ze-glioma yobuchopho eziyingozi kakhulu futhi okunzima ukuzelapha.
Ngemva kokuhlinzwa ngokuhlinzwa ngomhlaka-5 Januwari 2023, waqala ngokwelashwa okujwayelekile, kodwa isimo sakhe saphinde sabuya ngemuva kwesikhathi esifushane sokuqina. Ngemva kwalokho, welashwa nge-CAR-T engu-17 egxile kuma-antigen amabili ahlukene, kodwa isifo sakhe saqhubeka nokuthuthuka.
Ephelelwe yithemba, wabhalisa esivivinyweni somtholampilo sokwelashwa okusha kwe-TIL. Imiphumela yayimangalisa: emavikini amane nje ngemva kokufakwa kweseli le-TIL, ukuhlolwa kwezithombe kwabonisa ukuthi isimila ebuchosheni bakhe sase sisusiwe ngokuphelele, kwatholakala impendulo ephelele, futhi uhlale engenaso isimila izinyanga ezingaphezu kuka-20.
—
Ukulwela Ukusinda Esimweni Esinzima
I-Glioblastoma yaziwa ngokuthi “umbulali oyinhloko ongaphakathi kwekhanda.” Isikhathi sokuxilongwa sizwakala njengokuqala kokubala impilo yonke.
Ngemva kokuxilongwa kukaMnu. W, waqala ngokuhlinzwa ukuhlinzwa komdlavuza wobuchopho okwakuyingozi enkulu, kwalandela ukwelashwa ngamakhemikhali e-temozolomide kanye nokwelashwa ngemisebe. Kodwa-ke, isimo sakhe asizange silawulwe.
Ngemva kwalokho, wazama izindlela ezimbili zokwelapha ze-CAR-T ezihlose ama-antigen ahlukene, wathola imijovo engaphezu kweyishumi yangaphakathi kwesimila ihlangene, kodwa lokhu kwahluleka ukuvimba ukuqhubeka kwesimila.
Ukwelashwa kwendabuko kunomphumela olinganiselwe ekulweni ne-glioma yobuchopho ethuthukisiwe. Ngisho noma kunezinhlelo zokwelapha ezihlanganisiwe ezihilela ukuhlinzwa, ukwelashwa ngemisebe, kanye ne-chemotherapy, isilinganiso sokuphila seziguli cishe izinyanga ezingu-14.6 kuphela.
Bebhekene nesimo esinjalo esingenathemba, uMnu. W nomndeni wakhe bazizwa bephelelwe yithemba elikhulu kwaze kwaba yilapho bezwa ngesivivinyo sezokwelapha se-TIL.
Ukwelashwa kwe-TIL
Ukwelashwa kwe-TIL, noma ukwelashwa kwe-Tumor-Infiltrating Lymphocyte, kuyindlela entsha yokwelapha nge-immunotherapy yamaseli.
Lokhu kwelashwa kuqala ngezicubu ezintsha zesimila sesiguli njengezinto zokusetshenziswa. Ngemva kokuhlukaniswa, ukuguqulwa, kanye nokwandiswa ngaphandle kokusebenzisa i-vitro, amaseli aphinde afakwe esigulini, kufezwe ukwelashwa okunembile "okulwa nesimila ngokwaso."
Ngokungafani nokwelashwa kwe-CAR-T okuvamile, ukwelashwa kwe-GC101 TIL akudingi ukudonswa kwegazi noma imijovo ye-IL-2, okuthuthukisa kakhulu ukuphepha kanye nokulula kokwelashwa.
Ithuthukiswe yiJuncell Therapeutics, ukwelashwa kwe-GC101 TIL kuyindlela yokuqala yokwelapha yemvelo ye-TIL emhlabeni engadingi i-lymphodepletion noma umjovo we-IL-2, isebenzisa ipulatifomu yayo yokukhulisa amaseli e-DeepTIL® ezenzele yona.
Idatha yezokwelapha ekhona ikhombisa ukuthi i-GC101 inezinga lokuphendula eliqondile elidlula u-35% uma kuqhathaniswa nezinhlobo ezahlukene zezimila eziqinile ezithuthukile. Iziguli eziningana zifinyelele ekuqedeni isimila ngokuphelele kanye nokusabela okuphelele, kanti isikhathi eside kakhulu sokusinda ngaphandle kwesimila sidlula iminyaka emi-3.
Inqubo Yokwelapha
Ngasekupheleni kuka-2023, uMnu. W wabhalisa ngempumelelo esivivinyweni sokwelashwa kwe-GC101 TIL.
Ithimba lezokwelapha lisebenzise amaseli e-TIL akhuliswe esampula yakhe yokuhlinzwa atholwe ngonyaka odlule, ayegcinwe e-cryopreserved kuze kube yilapho edingeka.
Ithimba lokwelapha landise ngempumelelo amaseli afinyelela kumaseli e-TIL angu-2.95 × 10^10, kanti amaseli e-T aqukethe inani eliphezulu lama-99.92% labantu, ikakhulukazi amaseli e-T e-CD8⁺ (97.85%).
Ngemva kokulungiswa kusengaphambili, uMnu. W wathola ukufakwa kweseli le-TIL ngoDisemba 12, 2023.
Ngesikhathi enikwa umuthi, uMnu. W akazange abhekane nokusabela okubi kakhulu, umkhuhlane omncane kuphela owaphela ngokushesha. Uma kuqhathaniswa nokwelashwa kwendabuko kwe-TIL, le nguqulo eguquliwe ibonise ukuphepha okuphezulu.
Ukuguquka Okumangalisayo
Ngemva nje kwamasonto amane okufakwa kweseli le-TIL, ukuhlolwa kwezithombe ngoJanuwari 8, 2024, kwembula ukuthi isimila ebuchosheni bukaMnu. W sase sisusiwe ngokuphelele.
Okuphawuleka nakakhulu ukuthi, kusukela ngo-Okthoba 2025, isiguli besilokhu siphila iminyaka engaphezu kwengu-1.8 singenaso isimila (kubalwa ngesikhathi sokukhishwa kwezindaba, lokhu kungaphezu kwezinyanga ezingu-20), siphinde sithole impilo evamile.
Leli cala libeka irekhodi elisha lokusinda kwe-glioblastoma ephindaphindayo futhi linikeza ubufakazi obubalulekile bezokwelapha ngesu lokwelapha "lokuthatha amasampula ezicubu zakuqala, ukufakelwa kabusha kwe-TIL lapho kuphinde kuvele."
Le mpumelelo emangalisayo izovezwa kuphosta eMhlanganweni Waminyaka Yonke Wama-40 weNhlangano Yezokwelapha Ngezifo Zomdlavuza, ozoqala mhla ziyi-7 kuya ku-9 kuNovemba 2025, uboniswa ochwepheshe bemboni yomhlaba wonke.
Amathemba Esikhathi Esizayo
Ukwelashwa kwe-TIL kubonise amandla hhayi nje ekwelashweni kwe-glioma yobuchopho kodwa futhi kubonise ukusebenza okumangalisayo ngokumelene nezinye izimila eziqinile njenge-melanoma ethuthukisiwe kanye nomdlavuza wamaphaphu ongewona amaseli amancane.
NgoFebhuwari 2024, ukwelashwa kokuqala kwe-TIL cell emhlabeni, i-Lifileucel, kwavunyelwa yi-FDA e-United States ngokwelapha iziguli ezine-melanoma ethuthukile ezazithole ukwelashwa kwe-PD-1 inhibitor ngaphambilini.
Ngesikhathi esifanayo, iShayina ithuthukisa ngenkuthalo ucwaningo lwezokwelapha mayelana nokwelashwa kwe-TIL. Isivivinyo esibalulekile sokubhalisa seSigaba II somjovo we-GC101 TIL we-Juncell Therapeutics ohlose i-melanoma ethuthukisiwe sivunyiwe yi-Center for Drug Evaluation of the National Medical Products Administration.
Ngaphezu kwalokho, ngomhlaka-14 Okthoba 2024, kwaqalwa ngokusemthethweni ukuhlolwa kokuqala kokubhaliswa kwemithi yamaseli e-TIL eShayina ngqo umdlavuza wamaphaphu, okuhloswe ngakho ukwelapha umdlavuza wamaphaphu ongeyona iseli elincane othuthukile.
—
Njengamanje, kusenezivivinyo eziningi zemitholampilo zemithi emisha yokulwa nomdlavuza kanye nobuchwepheshe eShayina obufuna iziguli.
UMnyango Wezizwe Ngezizwe Wesibhedlela Se-Oncology saseBeijing South Region unikeza ukubonisana ngemithi emisha kanye nobuchwepheshe.
Inombolo yocingo: 4008803716
I-ID ye-WeChat: 17801183037
Email ①: 100085_010@163.com
Email ②: myimmnet@163.com
Isikhathi sokuthunyelwe: Novemba-20-2025