Ukwelashwa kwe-TIL (GT101)

I-GT101 iyindlela yokwelapha ngamaseli e-autologous eyenziwe nge-TIL enwetshiwe futhi evuselelwe esimilaneni sesiguli. Ukwelashwa kuphathwa ngokuqoqwa kwezicubu zesimila ezigulini bese kukhishwa i-TIL. I-TIL ekhishwe izobe isikhuliswa kusetshenziswa ipulatifomu yokukhiqiza ye-Grit Bio i-StemTexp® bese ifakwa ezigulini ukuze kulwiwe nezimila.

Ngo-2024Umhlangano Waminyaka Yonke We-American Society of Clinical Oncology (ASCO),Idatha ebikiwe ngeziguli eziyi-14 ezine-tumor eqinile ezibambe iqhaza ocwaningweni lwe-GT101. Lolu cwaningo lwaklanywa ngenhloso yokugcina eyinhloko yokuhlola i-DLT kanye nokuchaza iphrofayili yokuphepha ye-GT101 ezigulini ezine-tumor eqinile elinganiswe ngokwehla kwezehlakalo ezimbi ezivelela ukwelashwa zeBanga ≥ 3 (TEAEs). Imigomo yesibili kwakuwukuhlola amapharamitha okusebenza kahle okuhlanganisa izinga lokuphendula jikelele (ORR), izinga lokulawula izifo (DCR), ukusinda okungenalo ukuqhubekela phambili (PFS), ubude bempendulo (DOR), kanye nokusinda okuphelele (OS) ngokusho kwe-RECIST v1.1.

Imiphumela: Kusukela ngoNovemba 10, 2023, iqembu leziguli ezingu-14 lathola ukwelashwa okuphakathi kweminyaka engu-46.9 kanye nesilinganiso semigqa engu-2.6 yokwelashwa kwangaphambilini. Ngemva kokwelashwa okujwayelekile okusekelwe ku-FC, iziguli zanikezwa i-GT101 ngemithamo engu-≥ 5×109 ngamaseli anomthamo ophakathi wamaseli angu-3.7×1010, kulandelwa ukuphathwa kwe-IL-2 enomthamo ophezulu. Iningi lama-AE eBanga ≥ 3 abonwe lalihlobene nohlelo lokulungisa isimo se-FC kanye ne-IL-2, okuhlanganisa ukwehla kwenani lama-lymphocyte, ukwehla kwenani lamaseli amhlophe egazi, ukwehla kwenani lama-neutrophil, i-anemia, i-pyrexia kanye nokwehla kwenani lama-platelet. Iningi lala ma-AE lalulama zingakapheli izinsuku ezingu-14, kanti ambalwa ehliswe abe yi-≤ Ibanga lesi-2 zingakapheli amasonto ama-4. Phakathi kweziguli ezingu-14 ezibhalisiwe ngezinkomba ezahlukene (umdlavuza wamaseli amancane-amaphaphu, i-melanoma, umdlavuza wesibeletho), i-ORR yayingu-35.7%. Ngokuqondile, amaphuzu angu-4 (28.6%) abe nempendulo engaphelele eqinisekisiwe (PR), amaphuzu angu-1 (7.1%) athole impendulo ephelele (CR), kanti amaphuzu angu-8 (57.1%) abe nesifo esizinzile (SD) njengempendulo yawo engcono kakhulu. Iphuzu elilodwa lalinokuqhubeka kwesifo okungakaqinisekiswa (PD). Okuphawulekayo ukuthi, phakathi kweziguli ezingu-11/14 ezinomdlavuza wesibeletho, i-ORR yayingu-45.5% (5/11) kanti amaphuzu angu-4 (36.4%) athole i-PR kanye nephuzu eli-1 (9.1%) athole i-CR. Ukulawulwa kwesifo kwabonwa kumaphoyinti angu-10/11 (90.9%), kanti i-PFS ephakathi yayiyizinyanga ezingu-4.2 kuleli qembu. Isiguli se-CR salandelwa isikhathi eside kanti isikhathi se-CR kanye ne-PFS (esilinganiselwa nguKaplan-Meier) sasingamaviki angu-24 namaviki angu-36, ngokulandelana. Ngemuva kokufakwa kwe-GT101, iseli le-T landa kakhulu egazini elingaphandle lazo zonke iziguli ezine-Tmax ephakathi kwezinsuku ezingu-6.83 kanye nezinsuku ezingu-15.9 ezimaphakathi.

Iziphetho: Esifundweni se-GT101 Phase 1, awekho ama-SAE kanye ne-DLT ahlobene nokwelashwa abonwe. Ezigulini ezinezimila eziqinile ezithuthukisiwe noma ezisakazeke kakhulu, i-GT101 ibonise iphrofayili yokuphepha elawulekayo ngaphansi kwephrothokholi yokwelashwa kwe-lymphodepletion kanye ne-IL-2 yomthamo ophezulu kanye nephrofayili yomtholampilo enhle, ikakhulukazi kumdlavuza wesibeletho, ene-ORR ekhuthazayo kanye nesikhathi sokusabela esiqhubekayo.

Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

Inombolo yocingo: 4008803716

Email：myimmnet@163.com

Izinkomba

1.https://www.grit-bio.com/newsinfo/4620292.html

2.https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2548