Equecabtagene autoleucel (eque-cel)

Equecabtagene autoleucel (eque-cel), wani maganin T-cell na maturation antigen-targeting chimeric antigen receptor (CAR) wanda aka samo daga ɗan adam, ya nuna yuwuwar maganin sake dawowa ko rashin daidaituwar myeloma mai yawa (R/RMM).

A ranar 30 ga Yuni, 2023, Hukumar Kula da Kayayyakin Lafiya ta Kasa (NMPA) ta amince da Amfani da Sabbin Magunguna (NDA) ga FUCASO (Equecabtagene Autoleucel) , maganin T-cell na farko a duniya wanda aka yi wa cikakken maganin hana ƙwayoyin B (BCMA) chimeric antigen receptor (CAR) don maganin R/RMM wanda ya karɓi ≥ layuka 3 na magungunan da suka gabata waɗanda suka ƙunshi aƙalla maganin hana proteasome guda ɗaya da kuma maganin immunomodulatory.

A ranar 7 ga Nuwamba, 2024, IASO Biotherapeutics ta sanar da cewa sakamakon binciken asibiti na mataki na 1b/2 na FUMANBA-1 na maganin hana BCMA CAR-T gaba daya na dan adam, Equecabtagene Autoleucel (sunan kasuwanci: Fucaso™), don maganin R/RMM, an buga shi a cikin mujallar likitanci ta JAMA Oncology. Binciken ya kimanta inganci da amincin Equecabtagene Autoleucel a cikin marasa lafiya da ke fama da R/RMM waɗanda a baya suka karɓi layuka ≥3 na magungunan da suka gabata. Sakamakon ya nuna cewa Equecabtagene Autoleucel ya sami babban adadin amsawa gaba ɗaya da kuma sassauci mai ɗorewa ga marasa lafiya, tare da kyakkyawan bayanin aminci.

FUMANBA-1 wani bincike ne na asibiti mai rijista na hannu ɗaya, wanda aka gudanar a cibiyoyin 14 na ƙasar Sin don tantance inganci da amincin Equecabtagene Autoleucel ga marasa lafiya da ke fama da R/RMM waɗanda suka karɓi layuka ≥3 na magunguna a baya. Gwajin ya yi rajistar marasa lafiya da ke fama da R/RMM waɗanda a baya suka sami aƙalla layuka uku na magani, gami da masu hana proteasome da magungunan chemotherapy bisa ga magungunan immunomodulatory, kuma sun sami ci gaban cututtuka a layin maganinsu na ƙarshe. Marasa lafiya waɗanda suka taɓa shan maganin BCMA CAR-T a baya suma sun cancanci yin rajista.

SakamakoDaga cikin marasa lafiya 103 da aka yi wa allurar eque-cel, maza 55 (53.4%) ne, kuma matsakaicin shekarun (tsakanin) shine shekaru 58 (39-70). A lokacin bin diddigin matsakaicin (tsakanin) na watanni 13.8 (0.4-27.2), Dangane da inganci, daga cikin marasa lafiya 101 da za a iya kimantawa, jimillar adadin amsawar (ORR) shine 96.0% (97/101), kuma matsakaicin cikakken martani/cikakken martanin (sCR/CR) shine 74.3% (75/101). Daga cikin marasa lafiya 89 da ba su da maganin CAR-T a baya, ORR shine 98.9% (88/89), kuma ƙimar sCR/CR shine 78.7% (70/89). A cikin waɗannan marasa lafiya 101, matsakaicin lokacin amsawa shine kwanaki 16 (tsakanin: 11-179), yayin da matsakaicin tsawon lokacin amsawa (DOR) da matsakaicin rayuwa ba tare da ci gaba ba (PFS) ba tukuna. Matsakaicin PFS na watanni 12 shine 78.8% (95% CI: 68.6-86.0). Bugu da ƙari, 95% (96/101) na marasa lafiya sun sami ƙarancin rashin lafiyar da ta rage (MRD), tare da matsakaicin lokacin zuwa ga rashin lafiyar MRD na kwanaki 15 (tsakanin: 14-186). Duk marasa lafiya da ke da sCR/CR sun sami rashin lafiyar MRD, kuma ba a kai matsakaicin tsawon lokacin rashin lafiyar MRD ba.

Kammalawa da MuhimmanciA cikin wannan gwajin, eque-cel ya haifar da martani da wuri, mai zurfi, kuma mai ɗorewa ga marasa lafiya da ke fama da R/RMM da aka riga aka yi musu magani tare da yanayin aminci mai sarrafawa. Marasa lafiya da suka taɓa yin maganin CAR T-cell suma sun amfana da eque-cel.

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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Nassoshi

1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20230630195006116.html

2.https://en.iasobio.com/info.php?id=224

3.http://js.news.cn/20230926/c8e67444df624a5ea654dda3aa608689/c.html

4.https://en.iasobio.com/info.php?id=256

5.https://jamanetwork.com/journals/jamaoncology/article-abstract/2826068