- Ukwelashwa
- Ubufakazi
- I-Neuroblastoma
- Isimila Esiqinile
- Ubufakazi
- I-TILS
- Ukwelashwa Kwamaseli e-NK
- I-Myasthenia Gravis (MG)
- I-Acute Lymphoblastic Leukemia (B-ALL)
- I-Systemic Lupus Erythematosus (SLE)
- I-Acute Lymphoblastic Leukemia (T-ALL)
- I-Non-Hodgkin Lymphoma (NHL)
- I-Multiple Myeloma (MM)
- I-Diffuse Large B-cell Lymphom
- I-B-lymphocytic Leukemia
- I-Myeloma
Ukwelashwa kwe-CAR-T kwe-Myasthenia Gravis (MG)
Ukubuka konke
I-Myasthenia Gravis (MG) iyisifo esingapheli se-autoimmune neuromuscular esibangelwa ama-autoantibodies (ikakhulukazi ama-anti-acetylcholine receptor antibodies, i-AchRAb) aphazamisa ukuxhumana phakathi kwezinzwa nemisipha, okuholela ekubuthakathakeni okushintshashintshayo, i-ptosis, i-dysphagia, kanye nasezimweni ezimbi kakhulu ukwehluleka kokuphefumula okusongela impilo. Ezigulini ezine-MG engaphikisiyo ezihlulekayo ama-immunosuppressants avamile, ama-IVIG, ama-FcRn inhibitors, kanye nama-complement inhibitors, izinketho zokwelapha zihlala zilinganiselwe.
Ukwelashwa kwe-BIOOCUS okuqondiswe kabili kwe-CD19/BCMA CAR-T kumelela ukwelashwa kwamaseli e-autologous okuphumelelayo okuqeda ngokunembile amaseli e-B abangela izifo kanye namaseli e-plasma anesibopho sokukhiqizwa kwama-autoantibodies, okunikeza ithuba lokuphulukiswa okujulile nokuhlala isikhathi eside ku-MG okunzima ukwelapha.
Kuyini Ukwelashwa kwe-CAR-T kwe-MG?
Ukwelashwa kwe-CAR-T kwe-MG kuyindlela yokwelapha nge-immunotherapy ethuthukisiwe, eyenzelwe wena lapho amaseli e-T esiguli eklanywa khona ngokwezakhi zofuzo ukuze aveze ama-receptor e-chimeric antigen (ama-CAR) aqondise kokubili i-CD19 (kumaseli e-B) kanye ne-BCMA (kumaseli e-plasma). Ngemva kokunwetshwa elabhorethri, la maseli e-CAR-T aqondiswe kabili afakwa esigulini, lapho akhetha khona ukuqeda amaseli omzimba asebenza ngokuzenzakalelayo aqhuba i-MG, ngaleyo ndlela anciphise amazinga e-AchRAb futhi abuyisele umsebenzi wezinzwa.
Le ndlela yokwelapha okunezinjongo ezimbili ibhekana nezingxenye zamaseli kanye neze-humoral zempendulo yokuzivikela komzimba, ihlinzeka ngokusetha kabusha okuphelele kwesistimu yomzimba uma kuqhathaniswa nokwelashwa okunezinjongo eyodwa noma kwendabuko.
Izinzuzo Eziyinhloko Zokwelashwa Kwe-CAR-T Kwe-MG
- Ukuthuthuka kwezimpawu okusheshayo nokuqhubekayo: Ukuncipha okukhulu kokukhathala kwemisipha, i-ptosis, i-diplopia, i-dysarthria, kanye nobuthakathaka bemilenze.
- Ukuncipha kwamaseli e-B ajulile kanye namaseli e-plasma: Ukwehla okuphawulekayo nokuhlala njalo kwe-AchRAb kanye nenani eliphelele le-B-lymphocyte.
- Izikolo zemitholampilo ezithuthukisiwe: Inzuzo enkulu kumaphuzu e-Quantitative Myasthenia Gravis (QMG) kanye ne-Activities of Daily Living (ADL).
- Iphrofayili yokuphepha ethandekayo: Ibekezelelwa kahle ngaphandle kwe-cytokine release syndrome (CRS) noma ubuthi be-neurotoxicity obubonwa ezimweni ezelashwayo.
- Kungenzeka ukuthi kukhululwe isikhathi eside: Kunciphisa noma kuqeda isidingo sokucindezeleka kwamasosha omzimba okungapheli.
- Kwenziwe ngokwezifiso futhi kunembile: Isebenzisa amaseli esiguli uqobo, inciphisa ingozi yokwenqatshwa.
Inqubo Yokwelapha
- I-Leukapheresis– Ukuqoqwa kwamaseli e-T esiguli nge-peripheral blood apheresis.
- Ubunjiniyela Bezakhi Zofuzo– Amaseli e-T aguqulwa ukuze aveze ama-CD19 kanye nama-BCMA CAR futhi anwetshwa ezindaweni ze-GMP.
- Ukulungisa isimo (uma kudingeka)- Ukuncipha kwe-lymphodepletion okwesikhashana ukuze kuthuthukiswe ukufakwa kwe-CAR-T.
- Ukufakwa kwe-CAR-T– Ukufakwa okukodwa kwe-CD19 CAR-T ngemithambo yegazi (0.5×10⁶/kg) + BCMA CAR-T (1×10⁶/kg).
- Ukuqapha Nokulandelela– Ukuhlolwa okuvamile kokwanda kwe-CAR-T, amazinga e-AchRAb, ukubalwa kwamaseli e-B, amaphuzu e-QMG/ADL, kanye nokusebenza kwezitho kuze kube yizinyanga ezingu-12+.
Kungani Ukhetha Ukwelashwa Kwe-CAR-T Kwe-BIOOCUS Kwe-MG?
- Ipulatifomu ye-CD19/BCMA CAR-T esezingeni eliphezulu enezinhloso ezimbili elungiselelwe ngqo izifo zokuzivikela komzimba.
- Ithimba lokukhiqiza i-GMP elisezingeni lomhlaba kanye nethimba lokwelapha nge-immunotherapy elinolwazi olunolwazi kokubili ezimweni ze-hematologic monicancies kanye nezimo ze-autoimmune ezingasebenzi kahle.
- Ukusekelwa okuphelele kweziguli zomhlaba wonke: ukuxhumanisa izilimi eziningi, ukudluliselwa esikhumulweni sezindiza, indawo yokuhlala, kanye nokulandelwa kwesikhathi eside.
- Umlando oqinisekisiwe ku-CAR-T wezinkinga zokuzivikela komzimba (kufaka phakathi i-SLE) kanye nokuhlela ukwelashwa komuntu siqu.
- Ukunakekelwa okugcwele kusukela ekuhlolweni kwangaphambi kokwelashwa kuya ekuqaphelweni kwangemva kokufakwa.
Isifundo Sesiguli Esivelele: Owesifazane Oneminyaka Engu-20 (LYN) one-Refractory MG
Isizinda Sesiguli
- Kutholakale ukuthi une-Myasthenia Gravis engaphikisi (i-CNGIIIa, i-AchRAb-positive) kanye ne-thymoma/thymic hyperplasia yohlobo lwe-B3 ngemuva kokuhlinzwa.
- Izifo ezihambisana nalokhu: i-osteoporosis, ikhanda le-femoral elihlangene kanye ne-necrosis ye-avascular ye-proximal tibial yesobunxele, i-anemia yokuntuleka kwensimbi.
- Imigqa eminingi yokwelapha ehlulekile (2019–2025): ama-steroid anesilinganiso esiphezulu + i-azathioprine → i-tacrolimus → i-cyclosporine, i-IVIG ephindaphindwayo, i-efgartigimod, i-eculizumab + i-telitacicept, kanye ne-rituximab (500 mg, ayisebenzi kahle).
Ukwelashwa kwe-CAR-T
- Novemba 2025: Iphrothokholi ye-CAR-T yaqalwa; i-cyclosporine yamiswa okwesikhashana.
- Disemba 1, 2025: Ukuqoqwa kwamaseli egazi angaphandle kwe-mononuclear.
- Disemba 15, 2025: Ukufakwa kwe-CD19 CAR-T (0.5×10⁶/kg) + BCMA CAR-T (1×10⁶/kg).
- Azikho izehlakalo ezimbi kubonwe ngemuva kokumnika.
Imiphumela Yangemva Kokwelashwa (kusukela ngoMashi 2026)
- Ukwandiswa kwe-CAR-T: Ukwanda okusheshayo emzimbeni nge-CD19 CAR-T ephezulu ku-D10 (7.62%, 4.622×10⁷/L) kanye ne-BCMA CAR-T ku-D10 (17.17%, 1.0414×10⁸/L); ukutholwa okuqhubekayo kuze kube yiNyanga yesi-3.
- Ukuthuthukiswa Kwelabhorethri:
- Ukwehla okukhulu kwamazinga e-AchRAb kanye nokubalwa okuphelele kwe-B-lymphocyte.
- Ukubalwa kwegazi okuzinzile, ukusebenza kwesibindi nezinso.
- Amazinga e-immunoglobulin aqashwe (izinguquko zesikhashana ezilindelekile ngenxa yokuncipha kwamaseli e-B).
- Izikolo Zemitholampilo: Ukuthuthuka okuphawulekayo kumaphuzu e-QMG kanye ne-ADL, okubonisa ubuthakathaka bemisipha obunciphile kanye nokusebenza kangcono kwansuku zonke.
- Ukuqeda Izimpawu: Ukulungiswa noma ukuthuthuka okuphawulekayo ku-diplopia, ukuqina kobuso, i-dysarthria, kanye nokukhathala kwemilenze.
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