Glioblastoma Multiforme (GBM) yana ɗaya daga cikin cututtukan daji mafi muni, kuma kusan dukkan marasa lafiya suna fuskantar sake dawowa bisa ga tsarin kulawa na yanzu ga sabbin GBM da aka gano. GBM mai sake dawowa (rGBM) yana nuna matsakaicin rayuwa na ƙasa da watanni 8 tare da iyakantaccen zaɓuɓɓukan magani.
TX103 magani ne na maganin ƙwayoyin cuta na CAR-T wanda ke kai hari ga B7-H3, wanda aka haɓaka shi da kansa kuma aka ba shi izini tare da haƙƙin mallaka na China da na ƙasashen duniya. An gabatar da sakamakon farko na maganin TX103 don sake dawowar gliomas a taron shekara-shekara na Ƙungiyar Kula da Cututtukan Cututtuka ta Amurka (ASCO) a shekarar 2024.(NCT05241392).
Hanyoyi: Wannan bincike ne na buɗe hannu ɗaya, mai "ƙara yawan allurai 3+3" da kuma yawan allurai. Babban manufar ita ce a tantance aminci da kuma mafi girman adadin da aka yarda da shi. Manufofi na biyu sun haɗa da sakamakon rayuwa, martanin ƙari, martanin rigakafi, da kuma sigogin magunguna. An yi wa marasa lafiya 'yan shekara 18 zuwa 75 rajista tare da tabbatar da sake dawowa ta hanyar hoton hoto da kuma bayyanar B7-H3 >= 30% ta hanyar nazarin immunohistochemistry. An ba wa marasa lafiya TX103 a cikin rami da/ko a cikin ventricular ta hanyar ma'ajiyar Ommaya. An ba marasa lafiya TX103 sau biyu a mako a kowane zagaye a matakan allurai 1, 2, da 3 (ƙwayoyin halitta miliyan 20, 60, 150, bi da bi), tare da zagaye huɗu a matsayin kwas ɗaya.
Sakamako: Tsakanin Maris 2022 da Janairu 2024, marasa lafiya 13 sun sami aƙalla allurar TX103 guda ɗaya a cikin kwakwalwa, tare da marasa lafiya 3, 4, da 6 a matakan allurar 1, 2, da 3, bi da bi. Matsakaicin adadin zagayowar allurar shine 4 (Min, Max 1,9). An haɗa duk marasa lafiya a cikin nazarin aminci, wanda ya nuna babu wani guba da ke iyakance allurar ko mutuwar da ta shafi maganin CAR-T. Duk marasa lafiya sun sami aƙalla wani mummunan lamari (AE), kuma AEs masu alaƙa da magani (TRAEs) sun haɗa da ciwon sakin cytokine, ƙaruwar matsin lamba a cikin kwakwalwa (ICP), ciwon kai, farfadiya, raguwar sanin yakamata, amai, da kuma ciwon kai. Yawancin TRAEs sun kasance aji 1-2, yayin da aka lura da TRAEs guda uku na aji 3: wani lamari na ƙaruwar ICP a matakin allurai na 2, wani lamari na farfadiya, da wani lamari na raguwar matakin sani a matakin allurai na 3. Ya zuwa watan Janairun 2024, marasa lafiya shida daga matakan allurai na 1 da 2 sun cancanci a kimanta tsawon watanni 12 na rayuwa; jimlar rayuwar watanni 12 (OS) shine 83.3% (95% CI: 58.3% ~ 100%), kuma matsakaicin OS shine watanni 20.3 (95% CI: 20.3 ~ bai isa ba). Biyu daga cikin marasa lafiya uku daga matakin allurai na 2 sun sami martani na ɓangare da cikakke, bi da bi. Bayan shan CAR-T, an lura da ƙaruwa mai yawa a cikin cytokines, gami da IL-6 da IFN-γ, da kuma ƙaruwar adadin kwafin kwayar halittar CAR a cikin ruwan cerebrospinal, yayin da aka lura da ƙaramin ƙaruwa kawai a cikin jinin gefe.
Kammalawa: A cikin wannan gwajin, ana ɗaukar maganin rGBM da TX103 a matsayin lafiya kuma an jure shi. Waɗannan sakamakon na wucin gadi suna tallafawa ƙarin bincike ta amfani da TX103 don haɓaka sakamakon rayuwa ga marasa lafiya da rGBM.
A halin yanzu, akwai wasu gwaje-gwajen asibiti da yawa na CAR-T a China, kuma suna neman marasa lafiya. Don neman shawara kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Kasa da Kasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Email：myimmnet@163.com
Lokacin Saƙo: Disamba-09-2024