A ranar 7 ga Agusta, Cibiyar Kimanta Magunguna (CDE) ta Hukumar Kayayyakin Lafiya ta Ƙasa (NMPA) ta sanar da cewa an gabatar da allurar PA3-17 don haɗawa a cikin tsarin maganin gaggawa, wanda aka yi niyya don maganin manya marasa lafiya da suka sake kamuwa da cutar sankarar lymphoblastic mai tsanani ta T-cell (r/r T-ALL/LBL).
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Marasa lafiya da suka sake kamuwa da cutar T-lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL) suna bayyana a asibiti ta hanyar saurin ci gaban cutar, rashin kyakkyawan hasashen cutar da kuma rashin hanyoyin magani. A halin yanzu, FDA ta amince da Nailabine ne kawai a shekarar 2005 don maganin marasa lafiya na T-ALL/LBL waɗanda ba su amsa aƙalla tsarin chemotherapy guda biyu ba ko kuma suka sake komawa bayan magani, tare da ORR na 31% da CR na 23%. Saboda haka, akwai buƙatar gaggawa don haɓaka wasu hanyoyin da suka dace. Baya ga bayyanar ta a cikin ƙwayoyin T da NK na yau da kullun da rashin bayyanar cutar a cikin wasu ƙwayoyin nama, CD7 yana da matuƙar bayyana a cikin ƙwayoyin T-ALL/LBL. Saboda haka, ana ɗaukar CD7 a matsayin abin da zai iya zama manufa don haɓaka maganin CAR-T don T-ALL/LBL. Duk da haka, ƙalubalen shine a guji fratricide da bayyanar CD7 a cikin ƙwayoyin T ke haifarwa. Masu bincike sun ƙirƙiro allurar ƙwayoyin CAR-T bisa ga ƙwayoyin rigakafi nano na CD7, mai suna allurar PA3-17, ta hanyar toshe bayyanar ƙwayoyin CD7 a saman ƙwayoyin T ta hanyar hana bayyanar furotin na anti-CD7 (PEBL).
An gabatar da bayanai na dogon lokaci daga gwajin asibiti na Phase I na allurar PA3-17 don maganin cutar sankarar lymphoblastic mai saurin kamuwa da cutar T-cell (R/R T-ALL/LBL) a taron ilimi na duniya mai iko na EHA 2025.
Ya zuwa ranar 19 ga Fabrairu, 2025, jimillar marasa lafiya 13 aka yi wa rajista (masu lafiya 3 a cikin allurar 1, 2, 3, da marasa lafiya 4 a cikin rukunin RP2D), duk waɗanda aka yi musu allurar PA3-17 sau ɗaya kuma suka kammala tantance allurar da ke iyakance guba (DLTs) na kwanaki 28. An kafa RP2D a 2×10⁶ CAR-T/kg bisa ga pharmacokinetics, aminci da inganci fiye da wannan allurar. Babu DLT da ya faru kuma ba a kai matsakaicin adadin da aka yarda da shi ba (MTD). Yawan kamuwa da cutar Cytokine release syndrome (CRS) ya kai 84.6% (G3:23.1%, babu G4), yayin da ciwon neurotoxicity da ke da alaƙa da ƙwayoyin rigakafi (ICANS) ya takaita ga G1-2 (15.4%). Bayanan inganci sun nuna cewa mafi kyawun ƙimar amsawar da aka yi da gangan (ORR) shine 84.6% (11/13) kuma 76.9% (10/13) sun sami cikakkiyar gafara/cikakken gafara tare da murmurewa daga ƙididdigewa (CR/CRi). Abin mamaki, 69.2% (9/13, marasa lafiya 8 CR) sun ci gaba da amsawa a cikin watanni 3, tare da 50.0% (4/8) suna riƙe da CR~ watanni 15 bayan jiko ba tare da dashen ƙwayoyin tushe ba (SCT), kuma biyu daga cikinsu har yanzu suna da ƙwayoyin CAR-T da za a iya ganowa a cikin watanni 21. Abin lura shi ne, wani majiyyaci da aka yi masa magani sosai [kafin dashen ƙwayoyin tushe na Hematopoietic (HSCT), babban cuta ＞7cm] ya sami CR a rana ta 28 da kuma HSCT ta biyu a cikin watanni 6.
Allurar PA3-17 ta nuna kyakkyawan juriya, aiki mai zurfi da dorewa a asibiti ga marasa lafiya da ke fama da cutar r/r T-ALL/LBL da aka riga aka yi musu magani, inda kashi 50% na marasa lafiya na CR suka rage rayuwa ko/kuma ba su da ci gaba a shekara 1.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
Lambar Waya: 4008803716
Shaidar WeChat: 17801183037
Email：myimmnet@163.com
Lokacin Saƙo: Agusta-13-2025