Ukwelashwa kwe-CAR-T komdlavuza wesisu

I-Claudin18.2 (CLDN18.2) iyi-isoform yeprotheyini ehlanganisiwe ebonakala ngqo ku-epithelium yesisu futhi ebonakala kakhulu ebusweni bamaseli omdlavuza wesisu. I-CT041 (ikhodi yokuthuthukiswa i-CG4006) umkhiqizo we-CAR-T oqondiswe ku-CLDN18.2. Idatha yeSigaba I ikhombisa umsebenzi othembisayo wokulwa nomdlavuza ezigulini ezinomdlavuza wesisu ezilashwe kakhulu ngaphambi kwesikhathi, ezine-CLDN18.2.

Ukwanda kokubonakaliswa kwe-HER2 ngokweqile kubonakala naseqenjini elincane leziguli ezinomdlavuza wesisu. Izindlela zokwelapha ze-CAR-T eziqondiswe ku-HER2 zibonise amandla okulwa nomdlavuza ezifundweni zangaphambi kokwelashwa kanye nezasekuqaleni kwezokwelapha. I-TAC01-HER2 ye-Triumvira Immunologics okwamanje isezivivinyweni zezokwelapha zeSigaba II.

• Ukuqondiswa Okuqondile Kakhulu: Ngokuqondisa amaseli e-CAR-T ngokumelene ne-CLDN18.2 noma i-HER2, amaseli omdlavuza wesisu angabonakala futhi aqedwe ngokunembile, kuncishiswe imiphumela engaphandle kwesimila.

• Ukunqoba Ukumelana Nokwelashwa Okunemigqa Eminingi: Ezivivinyweni ze-CT041, iqembu lomdlavuza wesisu lithole izinga lokuphendula eliqondile (ORR) elingu-57.1%, izinga lokulawula izifo (DCR) elingu-75.0%, kanye nokusinda okuphelele kwezinyanga eziyi-6 (OS) okungu-81.2% ezigulini ezihlulekile emigqeni eminingi yokwelashwa ngaphambilini.

• Izimpendulo Ezihlala Isikhathi EsideUkwelashwa kwe-CLDN18.2-CAR-T kuveze izinga lokuphendula lezinyanga eziyi-6 elingu-44.8%, okuphakamisa amathuba enzuzo yesikhathi eside yezokwelapha.

• Ukwelashwa Okuqondene NakhoUkusebenzisa amaseli e-T esiguli kunciphisa ingozi yokwenqatshwa futhi kuthuthukisa ukuphepha nokusebenza kahle.

• Ukuqoqwa Kwamaseli Egazi Angaphandle
  Amaseli e-T ahlukaniswa egazini lesiguli elingaphandle nge-leukapheresis.

• Ubunjiniyela Bezakhi Zofuzo
  Elabhorethri ehambisana ne-GMP, amaseli e-T aguqulwa ukuze aveze i-CAR eqondise i-CLDN18.2 noma i-HER2, bese enwetshwa yi-ex vivo.

• Ukulungisa Ukuncipha Kwama-Lymphoma
  Kunikezwa uhlelo lokulungiselela lwe-cyclophosphamide ne-fludarabine ukuze kuncishiswe ama-lymphocyte angaphakathi futhi kudale indawo enhle yokwanda kwamaseli e-CAR-T.

• Ukufakwa Kweseli le-CAR-T
  Amaseli e-CAR-T aklanywe ngendlela ethuthukisiwe aphinde afakwe esigulini ngemithambo yegazi.

• Ukuqapha Nokuphatha
  Ngemva kokufaka umuthi, iziguli ziqashwe ngokucophelela ukuze zibone ukuthi azinazo yini izimpawu zokukhishwa kwe-cytokine (CRS) kanye nobuthi obuhambisana nobuchopho, ngokungenelela ngesikhathi esifanele njengoba kudingeka.

• Ukuhlaziywa Kwesikhashana Kwesigaba I se-CT041 (CLDN18.2-CAR-T)
  Phakathi kweziguli ezingu-37 ezelashwe kakhulu ngaphambi kwesikhathi, iqembu elincane lomdlavuza wesisu lathola i-ORR engu-57.1%, i-DCR engu-75.0%; abangu-94.6% bahlangabezane ne-CRS yeBanga loku-1–2 kuphela, bengenayo i-CRS yeBanga lesi-3 noma ngaphezulu noma ubuthi be-neurotoxicity; isikhathi sempendulo yezinyanga eziyi-6 sasingu-44.8%.

• Imiphumela Yokugcina Yesigaba I se-Satri-cel (ephinde ihlose i-CLDN18.2)
  Ezigulini ezingu-98 ezine-CLDN18.2 ezine-gastrointestinal cancer, i-ORR yayingu-38.8%, i-DCR ingu-91.8%; ukusinda okuphakathi okungenayo i-progression (mPFS) kwakuyizinyanga ezingu-4.4 (95% CI 3.7–6.6), ukusinda okuphakathi okujwayelekile (mOS) kwakuyizinyanga ezingu-8.8 (95% CI 7.1–10.2); abangu-96.9% babe ne-CRS yeBanga loku-1–2 kuphela, ngaphandle kwe-CRS yeBanga lesi-3+ noma ukufa okuhlobene.

• Idatha Yomtholampilo Yasekuqaleni Ye-HER2-CAR-T
  Ucwaningo lweSigaba I lokuqala kubantu lubonise iphrofayili yokuphepha elawulekayo; ukuhlolwa kokubhaliswa kweSigaba II kuyaqhubeka.

• Ipulatifomu Yobuchwepheshe Ehamba phambili
  I-BIOOCUS isebenzisa indawo yokukhiqiza amaseli e-GMP emhlabeni wonke, iqinisekisa ukukhiqizwa kwamaseli e-CAR-T okuphumelelayo nokuqhubekayo.

• Ithimba Lochwepheshe Abahlukahlukene
  Ithimba lethu lihlanganisa ochwepheshe abanolwazi kwezokwelapha ngezifo zomzimba, i-oncology, kanye nokwelashwa kwamaseli, abahlinzeka ngokuphathwa komuntu siqu ngokugcwele.

• Okuhlangenwe nakho Kwezokwelapha Kwamazwe Ngamazwe
  Siye salala iziguli ezivela emhlabeni wonke, siqoqa ulwazi oluningi lokuphepha nokusebenza kahle.

• Isevisi Ephelele Yokuphela Kosuku
  Kusukela ekwakhiweni kwephrothokholi kanye nokuhlanganiswa kokwelashwa kwamanye amazwe kuya ekulandelelweni kwesikhathi eside ngemva kokufakwa, i-BIOOCUS inikeza ukwesekwa okukodwa.