Uburyo bwo kuvura bwa BIOOCUS Medical Group Dual CD19/BCMA CAR-T butanga umusaruro mwiza mu ndwara ya Refractory Myasthenia Gravis: Urugendo rw'umurwayi ukiri muto
Myasthenia Gravis (MG) ni indwara idakira y’ubwiyongere bw’umubiri iterwa n’uturemangingo tw’umubiri (cyane cyane uturemangingo twa anti-acetylcholine receptor, AchRAb) tubangamira itumanaho ry’imitsi n’imitsi, bigatera intege nke zihindagurika, ptosis, dysphagia, no mu bihe bikomeye bishobora guteza akaga mu buhumekero. Ku barwayi bafite MG idashobora gusubiza imiti isanzwe igabanya ubudahangarwa bw’umubiri, IVIG, FcRn inhibitors, cyangwa imiti igabanya ubudahangarwa bw’umubiri, uburyo bwo kuvura bwari buke cyane kugeza ubu.
Uburyo bwa BIOOCUS Medical Group bwo kuvura CD19/BCMA CAR-T bufite intego ebyiri bugaragaza uburyo bushya bwo kuvura uturemangingo twitwa autologous cells, bukuraho neza uturemangingo twa B dutera indwara ndetse n’uturemangingo twa plasma dushinzwe gukora uturemangingo twitwa autoantibody. Ubu buryo bwo kuvura uturemangingo twitwa dual-target butanga ubushobozi bwo kugabanya cyane kandi burambye binyuze mu gukemura ibice by’uturemangingo n’ibice by’uturemangingo twitwa humoral.
Hari ikibazo cyerekana icyizere cy’ubuvuzi. Umurwayi w’umugore w’imyaka 20, witwa LYN, yasuzumwe indwara ya Myasthenia Gravis (CNGIIIa, AchRAb-positive) na thymoma/thymic hyperplasia yo mu bwoko bwa B3 nyuma yo kubagwa. Yanagize indwara zirimo osteoporosis, umutwe w’imbere mu gitsina n’umutwe w’ibumoso wa tibial avascular necrosis, hamwe no kubura icyuma. Nubwo yavuwe inshuro nyinshi kuva mu 2019 kugeza 2025—harimo imiti myinshi ya steroide hamwe na azathioprine, tacrolimus, cyclosporine, IVIG isubiwemo, efgartigimod, eculizumab hamwe na telitacicept, na rituximab (500 mg)—uburwayi bwe bwakomeje kugabanuka.
Mu Gushyingo 2025, protocole ya CAR-T yaratangijwe maze cyclosporine irahagarikwa. Uturemangingo tw’amaraso two mu bwoko bwa mononuclear twakusanyijwe ku ya 1 Ukuboza 2025. Ku ya 15 Ukuboza 2025, yahawe CD19 CAR-T (0.5×10⁶/kg) hamwe na BCMA CAR-T (1×10⁶/kg). Nta ngaruka mbi zagaragaye nyuma yo guhabwa imiti.
Kugeza muri Werurwe 2026, isuzuma ryakozwe ryagaragaje ko CAR-T yagutse cyane mu mubiri, aho CD19 CAR-T yageze ku munsi wa 10 (7.62%, 4.622 × 10⁷ / L) na BCMA CAR-T yageze ku munsi wa 10 (17.17%, 1.0414 × 10⁸ / L), byakomeje mu kwezi kwa 3. Iterambere rya laboratwari ryari rikubiyemo kugabanuka gukomeye kw'urugero rwa AchRAb n'umubare wose wa B-lymphocyte, hamwe n'umubare uhoraho w'amaraso, imikorere y'umwijima n'impyiko. Mu buvuzi, inyungu zigaragara zagaragaye mu manota ya Quantitative Myasthenia Gravis (QMG) na Activities of Daily Living (ADL). Ibimenyetso nka diplopia, kunanuka mu maso, dysarthria, no kunanirwa kw'amaguru byagaragaje ko byarushijeho kuba byiza cyangwa koroherwa cyane.
Uru rubanza rugaragaza ubushobozi bwo guhindura uburyo bwo kuvura bwa BIOOCUS Medical Group bwa CD19/BCMA CAR-T mu gutuma umubiri usubirana imbaraga zawo mu buryo bwimbitse kandi bukagira akamaro kanini mu kuvura indwara ya MG idashobora kugaragara. Ubu buryo bwo kuvura burihanganirwa neza, nta CRS cyangwa uburozi bw'ubwonko bwagaragaye, kandi bufite icyizere cyo koroherwa igihe kirekire mu gihe hagabanywa gukenera kwangirika k'ubudahangarwa bw'umubiri igihe kirekire.