RD13-02 samfurin ƙwayoyin CAR-T ne na duniya wanda ke nufin CD7 wanda aka samo daga masu ba da gudummawa masu lafiya, kuma an yi shi ne don maganin cutar sankarar lymphoblastic mai saurin kamuwa da cutar T-cell da ta sake dawowa ko kuma ta sake yin illa (T-ALL/LBL). Ana gyaggyara shi ta hanyar halitta don guje wa fratricide, cutar graft-versus-host (GvHD), da ƙin karɓar ƙwayoyin cuta (HvG) yayin da ake haɓaka aikin hana ƙari. Ana iya shirya RD13-02 a cikin rukuni ɗaya ga mutane da yawa, don cimma ƙarfin "ba tare da shirya ba" ga marasa lafiya da ke buƙatar maganin ƙwayoyin CAR-T.
A ranar 7 ga Nuwamba, 2024, Bioheng Therapeutics ta sanar da cewa za ta gabatar da sabbin bayanai na asibiti na Mataki na I game da samfurin ƙwayoyin CAR-T na duniya baki ɗaya RD13-02, wanda ke nufin CD7 don maganin marasa lafiya da suka sake kamuwa/rage (R/R) T-ALL/LBL, a cikin gabatarwa ta baki a taron shekara-shekara na 66 na Ƙungiyar Kula da Cututtukan Jini ta Amurka (ASH). Taron zai gudana daga 7-10 ga Disamba, 2024, a San Diego, Amurka.
Sakamako: Ya zuwa ranar 1 ga Agusta, 2024, an yi wa jimillar maki 18 da suka cancanta rajista tare da R/R T-ALL/LBL (13 ALL, 5 LBL), tare da matsakaicin shekaru na shekaru 33.5 (tsakanin, 11 zuwa 67). Matsakaicin layin maganin da aka yi a baya shine 2 (tsakanin, 1 zuwa 5), kuma maki 4 suna da allo-HSCT kafin yin rajista. Matsakaicin adadin fashewar BM shine 71% (tsakanin: 6% zuwa 90%) tsakanin maki 18, tare da 9 (6 ALL, 3 LBL) da ke nuna shiga tsakani na waje. Ba a lura da wani abu mai iyakance yawan guba (DLT) ko gubar jijiyoyi a duk matakan allurai ba, tare da shari'a ɗaya kawai ta Gr1 GvHD da ke faruwa. Ana iya sarrafa cutar Cytokine release syndrome (CRS) tare da mafi yawansu suna da sauƙi (Gr1, n=10; Gr2, n=5; Gr3, n=3). An sami kamuwa da kowace irin cuta a cikin maki 13 (72%) (≥Gr3 a cikin maki 2 [11%)). Saboda faruwar Gr3 CRS a cikin maki ɗaya kowanne daga matakan DL2 da DL3, masu bincike sun sanya DL1 a matsayin adadin faɗaɗawa tare da mai da hankali kan aminci da inganci. A lokacin faɗaɗa allurar, mutum ɗaya ya mutu sakamakon cutar tumor lysis a Rana ta 20 bayan allurar.
A gwajin farko na kwanaki 28 bayan allurar, maki 14 cikin 17 masu kimantawa sun cimma CR/CRi. Yayin da a cikin wata na 2 bayan allurar, ƙarin maki biyu sun kai CR/CRi, tare da ƙimar CR/CRi na 94% (16/17). Daga cikin maki tare da CR/CRi, kashi 100% sun sami ƙarancin yanayin rashin lafiyar da ta rage (MRD) ta hanyar nazarin cytometry na kwarara. Matsakaicin Cmax na ƙwayoyin CAR-T a cikin jinin gefe shine kwafi 1,863,601/μg genomic DNA (tsakanin, 275,044 zuwa 3,763,587) ta qPCR, tare da tsawon lokaci mafi tsawo fiye da kwanaki 90.
Kammalawa: RD13-02, wani samfurin CAR-T na duniya wanda ba a shirya shi ba, ya nuna ingantaccen bayanin aminci da ingantaccen tasiri wajen magance R/R CD7 T-ALL/LBL. Abin lura shi ne, kashi 100% na CR/CRi pts sun sami matsayin MRD-negative, suna ba da zaɓuɓɓukan magani cikin sauri.
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.
Lambar Waya: 4008803716
Email：myimmnet@163.com
Nassoshi
1.https://www.bioheng.com/News_Details/26.html
2.https://ash.confex.com/ash/2024/webprogram/Paper207322.html
3.http://myimm.net/mianyizhiliao/2035.html
Lokacin Saƙo: Disamba-03-2024