Ku ya 7 Kanama, Ikigo gishinzwe Isuzuma ry'Imiti (CDE) cy'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi (NMPA) cyatangaje ko hatanzwe inshinge za PA3-17 kugira ngo zishyirwe mu cyiciro cy'ubuvuzi bugezweho, bugenewe kuvura abarwayi bakuru bafite kanseri y'imitsi ya T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL).
Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.
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Abarwayi bafite indwara ya T-lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL) yasubiwemo/yasubiwemo (r/r T-ALL/LBL) bagaragazwa n'indwara zigenda ziyongera vuba, uburwayi buke ndetse no kubura uburyo bwo kuvura. Muri iki gihe, Nailabine ni yo yonyine yemejwe na FDA mu 2005 ku kuvura abarwayi ba T-ALL/LBL batakiriye nibura imiti ibiri ya chimiotherapie cyangwa basubiwemo nyuma yo kuvurwa, bafite ORR ya 31% na CR ya 23%. Kubwibyo, hari hakenewe byihutirwa gushyiraho ubundi buryo bwiza. Uretse kugaragara kwayo mu tunyangingo twa T na NK dusanzwe kandi nta kugaragara kwayo mu tunyangingo, CD7 igaragara cyane mu tunyangingo twa T-ALL/LBL. Kubwibyo, CD7 ifatwa nk'intego ishobora guteza imbere ubuvuzi bwa CAR-T kuri T-ALL/LBL. Ariko, ikibazo ni ukwirinda fratricide iterwa no kugaragara kwa CD7 mu tunyangingo twa T. Abashakashatsi bakoze inshinge za CAR-T zishingiye ku basirikari ba CD7 nano, bise inshinge za PA3-17, babuza igaragara rya molekile ya CD7 ku buso bw'uturemangingo twa T binyuze mu muyoboro urinda ishyirwa mu bikorwa rya poroteyine ya CD7 (PEBL).
Amakuru y’igihe kirekire yavuye mu igeragezwa rya Phase I ry’inshinge za PA3-17 mu kuvura kanseri y’amaraso ya T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) yatanzwe mu nama mpuzamahanga y’ubushakashatsi ya EHA 2025.
Ku itariki ya 19 Gashyantare 2025, abarwayi 13 bose hamwe nibo biyandikishije (abarwayi 3 bari mu itsinda rya 1, 2, 3, abarwayi 4 bari mu itsinda rya RP2D), bose bahawe urushinge rumwe rwa PA3-17 kandi barangije isuzuma ry’iminsi 28 rigabanya uburozi (DLTs). RP2D yagaragajwe kuri 2 × 10⁶ CAR-T/kg hashingiwe ku mikorere y’imiti, umutekano n’ubushobozi burenze iyi dose. Nta DLTs zabayeho kandi dose ntarengwa yihanganirwa (MTD) yagezweho. Icyorezo cya Cytokine release syndrome (CRS) cyari 84.6% (G3: 23.1%, nta G4), mu gihe indwara y’uburozi ifitanye isano n’imitsi (ICANS) yari igarukira kuri G1-2 (15.4%). Imibare y’imikorere yagaragaje ko igipimo cyiza cyo gusubiza neza (ORR) cyari 84.6% (11/13) naho 76.9% (10/13) babashije kuruhuka burundu/kuruhuka burundu hamwe no kugarura umubare utuzuye (CR/CRi). Igitangaje ni uko 69.2% (9/13, abarwayi 8 CR) bakomeje gusubiza nyuma y’amezi 3, naho 50.0% (4/8) bagumanye CR＞amezi 15 nyuma yo guterwa umuti nta gutera uturemangingo tw’ingirabuzimafatizo nyuma (SCT), kandi babiri muri bo bari bagifite uturemangingo twa CAR-T dushobora kugaragara nyuma y’amezi 21. Igishimishije ni uko umurwayi wavuwe cyane mbere [mbere yo gutera uturemangingo tw’ingirabuzimafatizo twa Hematopoietic (HSCT), indwara ikomeye cyane ＞cm 7] yageze kuri CR ku munsi wa 28 n’uwa kabiri HSCT ku mezi 6.
Urushinge rwa PA3-17 rwagaragaje ko rufite ubushobozi bwo kwihanganira indwara, imikorere y’ubuvuzi ikomeye kandi irambye ku barwayi bavuwe mbere y’uko bavurwa, aho 50% by’abarwayi ba CR bakomeza kubaho cyangwa/kandi nta ngaruka mbi bafite ku mwaka umwe.
Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.
Nimero ya Terefone: 4008803716
Indangamuntu ya WeChat: 17801183037
Email：myimmnet@163.com
Igihe cyo kohereza: Kanama-13-2025