Ngomhlaka-12 Meyi 2025, i-CARsgen imemezela idatha yokuqala yezokwelapha ye-CT0596, i-CAR-T eqondiswe ku-BCMA eyenziwe kusetshenziswa ipulatifomu ye-THANK-u Plus™. I-CT0596 okwamanje ihlolwa ocwaningweni lokuqala lwezokwelapha lokuhlola i-relapse/refractory multiple myeloma (R/R MM) noma i-relapse/refractory plasma cell leukemia (R/R PCL) ukuhlola ukuphepha kwayo, kanye nokusebenza kwayo kokuqala.
Kusukela ngomhlaka-6 Meyi 2025, iziguli ezingu-8 ezine-R/R MM ezazithole okungenani imigqa emithathu yokwelashwa ngaphambilini zabhaliswa futhi zafakwa i-CT0596 ngemuva kokususwa kwe-lymphocyte ngohlelo lwe-FC (i-fludarabine 22.5-30 mg/m² kanye ne-cyclophosphamide 350-500 mg/m²). Okutholakele okubalulekile kusukela ezinyangeni ezine zokulandelela kufaka phakathi:
Akukho ubuthi obukhawulela umthamo (ama-DLT), i-≥Grade 3 cytokine release syndrome (CRS), i-immune effector cell-associated neurotoxicity syndrome (ICANS), noma isifo se-graft-versus-host (GVHD) esibikiwe. Umkhiqizo ubonise iphrofayili yokuphepha enhle, kungekho ziguli eziyekile ukwelashwa ngenxa yezehlakalo ezimbi.
1) Phakathi kweziguli ezi-5 eziqede ukuhlolwa kokuqala kokusebenza kahle eSontweni lesi-4, iziguli ezi-3 (60%) zithole impendulo ephelele eqinile/impendulo ephelele (sCR/CR), kanye neziguli ezi-4 (80%) zithole isifo esincane esisele (MRD) - ukunganaki emnkantsheni wethambo. 2) Idatha yokusebenza kahle kwasekuqaleni evela ezigulini ezi-2 ngosuku lwe-14 ibonise ukwehla kwezilonda ezilinganiswayo ngo-≥92% kanye no-≥65%, ngokulandelana. 3) Isiguli esi-1 sasingakafiki esikhathini sokuhlola ukusebenza kahle esichazwe yiphrothokholi.
Zonke iziguli ze-sCR/CR zihlale zisabela ngokuqhubekayo, okuhlanganisa nesiguli sokuqala esaqeda ukulandelwa kwezinyanga ezine.
Ngokusekelwe kudatha yokuqala yokuphepha nokusebenza kahle, i-CT0596 ibonise ukubekezeleleka okuhle nokukhuthaza izimpawu zokusebenza kahle ezigulini ze-R/R MM kuwo wonke amazinga omthamo achazwe kusengaphambili, kwabonwa ukwanda kwe-CAR-T. Lokhu okutholakele kudinga ukuhlolwa okwengeziwe hhayi kuphela ku-R/R MM, kodwa nakwezinye izifo ezibangelwa amagciwane e-plasma cell kanye nezifo zokuzivikela komzimba ezibangelwa amangqamuzana e-plasma asebenza ngokuzenzakalelayo.
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
Isikhathi sokuthunyelwe: Meyi-15-2025