Ubushakashatsi bw'Iterambere Bwemeje Umutekano n'Ingufu z'Ubuvuzi bwa CD19/CD20 CAR-T kuri r/r B-NHL
Ubushakashatsi bushya bwasohotse muri Amarasoigaragaza iterambere ryiza rya prizloncabtagene autoleucel (prizlon-cel), uburyo bushya bwo kuvura selile za CAR-T zigamije CD19/CD20, mu kuvura selile za B zisubira inyuma/zidakora neza. Lymphoma itari iya Hodgkin (r/r B-NHL). Igerageza, icyiciro cya mbere, ubushakashatsi bw’ibigo byinshi, bwakorewe mu Bushinwa, butanga amakuru yizewe ku mutekano n’ubushobozi bw’ubu buryo bugamije ibintu bibiri.
Iyobowe n'itsinda ry'abashakashatsi bakomeye bo mu bigo birimo Ibitaro bya Mbere by’Ihuriro bya Kaminuza ya Zhejiang na Kaminuza ya Tongji, ubushakashatsi bwagaragaje abarwayi 48 bafite r/r B-NHL, benshi muri bo bakaba ari benshi. Lymphoma y'uturemangingo twa B (LBCL). Mbere abarwayi bari barahawe uburyo bwo kuvura bugera ku byiciro bitatu. Abitabiriye inama bahawe uburyo bumwe bwa prizlon-cel nyuma yo guhabwa imiti ya lymphodepleting, aho doze zitandukanye mu byiciro bitatu (DL1, DL2, na DL3).
Ibyavumbuwe by'ingenzi:
- Umwirondoro w'umutekano: Nta burozi bugabanya urugero rw'umuti (DLT) bwagaragaye, kandi uburyo bwo kuvura bwagaragaje ingaruka mbi zishobora gukemuka. Indwara ya Cytokine release syndrome (CRS) yagaragaye ku barwayi 93.8%, abenshi mu bari mu cyiciro cya 1-2, aho umuntu umwe gusa wo mu cyiciro cya 3 yari afite ikibazo. Indwara ya immunotoxicity syndrome (ICANS) yari idasanzwe kandi yoroheje, nta ngaruka zo mu cyiciro cya 3 cyangwa hejuru yayo.
- Ingufu: Igipimo rusange cy’ubwitabire (ORR) cya 91.5% cyagezweho, aho igipimo cyuzuye cy’ubwitabire (CR) cya 85.1%. Mu barwayi ba LBCL, igipimo cya ORR na CR cyari 90.7% na 86.0%, uko bikurikirana. Igitangaje ni uko 48.9% by’abarwayi bagumanye CR mu ikurikiranwa rya nyuma, bamwe mu barwayi barenza imyaka itatu.
- Ingaruka zo kurokoka: Ibigereranyo bya Kaplan-Meier byagaragaje ko igihe cy'imyaka 2 cyo gusubiza (DOR), igihe cyo kubaho kidahinduka (PFS), n'igihe cyo kubaho muri rusange (OS) cya 66.0%, 62.6%, na 76.5%, uko bikurikirana. Ku barwayi ba CR, ibi bipimo byari hejuru cyane.
Prizlon-cel yagaragaje kwaguka gukomeye no kuramba igihe kirekire, aho igihe cyo gukira kw'uturemangingo twa B cy'iminsi 185. Imiterere yayo ifite intego ebyiri ikemura ikibazo cyo gutoroka kwa antigen, uburyo busanzwe bwo kurwanya indwara mu buvuzi bwa CAR-T.