A watan Agusta na 2025, Cibiyar Nazarin Magunguna (CDE) ta Hukumar Kula da Kayayyakin Lafiya ta Ƙasa (NMPA) ta ba da izinin Naɗin Breakthrough Therapy ga Ina-cel, wani sabon maganin ƙwayoyin CAR-T da CD19 ke jagoranta wanda Juventas ta haɓaka daban-daban, don maganin marasa lafiya na yara da ke fama da cutar sankarar lymphoblastic mai saurin kamuwa da cutar B-cell (r/r B-ALL).
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
Inaticabtagene autoleucel (Inati-cel) samfurin ƙwayoyin T-cell ne na musamman na CD19-specific chimeric antigen receptor (CAR), wanda ke ɗauke da CD19 scFv wanda aka samo daga clone HI19α da kuma 4-1BB/CD3-ζ costimulatory domain, wanda aka amince da shi a China ga manya marasa lafiya da suka sake kamuwa ko suka kamu da cutar sankarar lymphoblastic B-acute (r/r B-ALL) a watan Nuwamba 2023.
TheTaron Shekara-shekara na ASCO na 2025 rahoto Binciken duniya mai cibiya da yawa, wanda ba shi da hannu a cikin ainihin duniya (NCT06450067) don tantance Inati-cel ga manya marasa lafiya na B-ALL. Tsakanin 20 ga Nuwamba, 2023, da 13 ga Nuwamba, 2024, marasa lafiya 62 sun karɓi Inati-cel kuma an kimanta su. Matsakaicin shekaru shine shekaru 37.5 (tsakanin, 14-76), tare da marasa lafiya 13 masu shekaru ≥60. A lokacin tantancewa, shari'o'i 16 sun sake dawowa bayan dasa ƙwayoyin halittar jini (HSCT), shari'o'i 4 ba su da tushe, kuma sama da kashi 70% na marasa lafiya suna ɗauke da mummunan yanayin kwayoyin halitta mai haɗari. Matsakaicin adadin jiko shine 0.60 (tsakanin: 0.46-0.9) × 10Kwayoyin halitta masu rai na 8CAR-T.
Sakamako: Bayanan da aka samu a ranar 30 ga Disamba, 2024, tare da matsakaicin bin diddigin watanni 3.8 (tsakanin: watanni 0.5–12.4), kashi 89.5% sun sami MRD-negative ORR bayan Inati-cel a cikin marasa lafiya na r/r, ciki har da 31 tare da CR da 3 tare da CRi (tebur 1). Marasa lafiya tara da ke da MRD-positive a lokacin gwajin, ƙimar MRD-negativity ta kai 100% bayan Inati-cel. Bayan Inati-cel, marasa lafiya 26 sun sami sakamakon MRD ta hanyar q-PCR, kuma 92.3% sun sami sakamako mara kyau. Bayan cimma CR/CRi, marasa lafiya 4 daga baya sun yi allurar allo-HSCT a cikin sassauci. Ba a kai matsakaicin DOR, OS da RFS tare da kuma ba tare da yin bincike ga marasa lafiya a allo-HSCT na gaba ba. Daga cikin marasa lafiya da za a iya kimantawa, ƙimar RFS da DOR na shekara 1 sune 76.2% da 74.1%, bi da bi. Marasa lafiya bakwai sun fuskanci sake dawowa, ciki har da sake dawowar CD19+ sau 3, sake dawowar CD19 sau 2, da kuma 2 waɗanda ba su san matsayin CD19 ba. Ya kamata a lura cewa a cikin shari'o'i 6 na cutar extramedullary, shari'o'i 4 sun yi tasiri, amma shari'o'i 2 sun sake dawowa cikin watanni 3 bayan Inati-cel. Duk marasa lafiya da aka yi wa jiko na Inati-cel suna da rai, sai dai mutuwa ɗaya daga ci gaban cutar. Abubuwan da suka fi haifar da rashin lafiya (AEs) sune cututtukan cytokine release syndrome (CRS) da kuma cututtukan neurotoxicity da ke da alaƙa da garkuwar jiki (ICANS). Kashi hamsin da ɗaya cikin ɗari na marasa lafiya sun kamu da CRS, amma CRS da ICANS na aji 3 ko sama sun faru ne kawai a cikin kashi 3.2% da 1.6% na marasa lafiya, bi da bi; duk marasa lafiya suna murmurewa ba tare da sake dawowa ba, babu mutuwar da ta shafi AE.
Amfani da Inati-cel a zahiri yana nuna babban ORR mai kama da MRD a cikin B-ALL na manya. An iya sarrafa bayanin lafiyar, tare da ƙarancin yawan CRS da ICANS masu maki ≥3 a cikin yanayin duniya na ainihi. Za a gabatar da bayanan bin diddigin lokaci mai tsawo.
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-26-2025