Ku ya 30 Nyakanga, Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi (NMPA) cyemeje ku mugaragaro kwamamaza HICARA mu kuvura abarwayi bakuru bafite lymphoma ya B-cell lymphoma yasubiwemo cyangwa idashobora kuvura (r/r LBCL) bahawe uburyo bubiri cyangwa burenze bwo kuvura umubiri. Ibi birimo lymphoma ya B-cell lymphoma ikwirakwira, itavuzwe ukundi (DLBCL, NOS); lymphoma ya B-cell lymphoma yahinduwe kuva kuri follicular lymphoma; lymphoma ya B-cell lymphoma yo mu rwego rwo hejuru hamwe na MYC na BCL2 rerrangements; na lymphoma ya B-cell lymphoma yo mu rwego rwo hejuru, itavuzwe ukundi (HGBL, NOS).
Ibi ni byo bigaragazwa n’umuti wa mbere w’ubushinwa wa CD19 CAR-T wakozwe mu gihugu hose, wibanda cyane cyane ku ndwara ya lymphoma nini ya B-cell B (r/r LBCL). Ubushakashatsi, iterambere, n’ikorwa rya HICARA bishingiye ku miterere ya Hrain Biotechnology, sisitemu yihariye y’ubuziranenge bw’imikorere, n’urusobe rw’umuti rufunganye rw’umuti munini. Iyi ntambwe igera ku iterambere ryuzuye ry’uturemangingo twa CAR-T, bigatuma habaho kwiharira ikoranabuhanga mu mahanga. Ikigaragara ni uko HICARA ari yo muti wa mbere wemewe mu gihugu wa CAR-T wakoresheje inzira ihamye y’uturemangingo.
Dukurikije ibyavuye mu igerageza rya HRAIN01-NHL01-II ry’icyiciro cya kabiri (NCT05436223) ryatanzwe mu nama ngarukamwaka y’ishyirahamwe ry’Abanyamerika rishinzwe ubushakashatsi ku ndwara ya kanseri (AACR) yo mu 2024, HICARA yagaragaje uburyo bwiza bwo kuvura abarwayi barwaye lymphoma itari Hodgkin yasubitse/yasubiye inyuma.
Ibisubizo: Ku ya 16 Gicurasi 2023, abarwayi 81 ba R/R NHL bafite ECOG 0-1 ku ikubitiro bahawe infusion ya HR001 n'ikigo gikora Jinshan [51.9% by'abagabo; impuzandengo y'imyaka 53.4 (ibara riri hagati ya 23 na 74); 3.7% CD19 negative; 91.4% bakwirakwiza lymphoma nini ya B-cell; 79.0% III-IV by'itsinda rya Ann Arbor cyangwa Lugano] hamwe n'impuzandengo y'iminsi 160 (ibara riri hagati ya 7 na 454). Igihe cyo hagati cyo gusubiza neza cyari iminsi 30 (ibara riri hagati ya 28 na 358). Igipimo cy'amezi 3, amezi 6 n'igipimo cyiza cyo gusubiza (ORR) cyari 53.1% (95% CI: 41.7-64.3), 45.7% (95% CI: 34.6-57.1) na 74.1% (95% CI: 63.1-83.2) uko bikurikirana. Igipimo cy'amezi 3, amezi 6 n'igipimo cyiza cyo gusubiza (CRR) cyari 32.1% (95% CI: 22.2-43.4), 29.6% (95% CI: 20.0-40.8) na 49.4% (95% CI: 38.1-60.7) uko bikurikirana. Igihe cy'igisubizo (DOR) n'igihe cyo kubaho kidashingiye ku iterambere (PFS) cyari iminsi 339 (95% CI: 149-NE) n'iminsi 176 (95% CI: 91-NE) uko bikurikirana. Kurokoka muri rusange (OS) ntikwagezweho. Indwara zikunze kugaragara cyane zijyanye n'ubuvuzi (AEs) zabaye mu buryo bw'amaraso. Indwara ya cytokine release syndrome (CRS) yagaragaye ku barwayi 95.1%, aho CRS yo mu rwego rwa ≥3 yagaragaye ku barwayi 3.7%. Indwara ya immunotoxicity syndrome (ICANS) yagaragaye ku barwayi 8.6%, nta ICANS yo mu rwego rwa ≥3 yagaragaye. Impfu zijyanye n'ubuvuzi zari 1.2%. Igihe cyo hagati cyo kwiyongera kw'uturemangingo twa CAR T cyari amasaha 240 (120 ~ 672) nyuma yo guterwa, kwiyongera kw'igipimo cy ...0-28dyari kopi 3201014.0/μg ADN (205082.8 ~ 18400016.2). Ibizamini byagaragaje ko antibody irwanya imiti (ADA) byagaragaye muri 14.8% by'abarwayi, mu gihe ibyavuye mu bushakashatsi ku ndwara ya antibody (Nab) byagaragaye ko ari 3.7% by'abarwayi. Mu barwayi bafite Nab, igisubizo cyuzuye cyakomeje kugaragara kugeza igihe bakurikiranwe.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department. Phone Number：4008803716 WeChat ID: 17801183037 Email：myimmnet@163.com
Igihe cyo kohereza: 31 Nyakanga-2025