Ọgwụgwọ CD19/BCMA nke BIOOCUS Medical Group Dual CAR-T na-enye nsonaazụ dị mma na Myasthenia Gravis na-adịghị mma: Njem Onye Ọrịa Na-eto Eto
Myasthenia Gravis (MG) bụ ọrịa neuromuscular autoimmune nke na-akpata autoantibodies (karịsịa anti-acetylcholine receptor antibodies, AchRAb) nke na-emebi nkwurịta okwu akwara na akwara, na-eduga na adịghị ike na-agbanwe agbanwe, ptosis, dysphagia, na n'ọnọdụ ndị siri ike nke na-eyi ndụ egwu iku ume. Maka ndị ọrịa nwere MG na-anaghị anabata ọgwụ mgbochi ọrịa nkịtị, IVIG, FcRn inhibitors, ma ọ bụ ihe mgbochi ndị ọzọ, nhọrọ ọgwụgwọ ejedebela - ruo ugbu a.
Ọgwụgwọ CD19/BCMA CAR-T nke BIOOCUS Medical Group na-anọchite anya ọgwụgwọ sel autologous ọhụrụ nke na-ewepụ mkpụrụ ndụ B na-akpata ọrịa na mkpụrụ ndụ plasma nke na-akpata mmepụta antibody. Usoro a na-akpata ihe abụọ na-enye ohere maka mgbaghara miri emi na nke na-adịgide adịgide site n'ịgwọ ma akụkụ sel na humoral nke nzaghachi autoimmune.
Otu ikpe a na-egosi nkwa ọgwụgwọ ahụ. A chọpụtara na otu nwanyị dị afọ iri abụọ, onye ọrịa a na-akpọ LYN, nwere Myasthenia Gravis (CNGIIIa, AchRAb-positive) na thymoma/thymic hyperplasia nke ụdị B3 mgbe ịwa ahụ gasịrị. O nwekwara nsogbu ndị ọzọ gụnyere osteoporosis, isi femoral bilateral na left proximal tibial avascular necrosis, na ụkọ iron. N'agbanyeghị ọtụtụ usoro ọgwụgwọ site na 2019 ruo 2025 - gụnyere steroids dị elu yana azathioprine, tacrolimus, cyclosporine, IVIG ugboro ugboro, efgartigimod, eculizumab gbakwunyere telitaccept, na rituximab (500 mg) - ọnọdụ ya ka dị n'enweghị njikwa.
Na Nọvemba 2025, e bidoro usoro CAR-T ma kwụsịtụrụ cyclosporine. A chịkọtara mkpụrụ ndụ mononuclear ọbara dị n'akụkụ na Disemba 1, 2025. Na Disemba 15, 2025, o natara ọgwụ CD19 CAR-T (0.5×10⁶/kg) tinyere BCMA CAR-T (1×10⁶/kg). Ahụghị ihe ọjọọ ọ bụla mgbe a mịnyechara ya ọgwụ.
Ka ọ na-erule Maachị 2026, nyocha ndị e mere gosiri mmụba ngwa ngwa nke CAR-T n'ime ndụ, yana CD19 CAR-T kachasị elu na ụbọchị nke iri (7.62%, 4.622×10⁷/L) na BCMA CAR-T na ụbọchị nke iri (17.17%, 1.0414×10⁸/L), nke a nọgidere ruo ọnwa nke atọ. Mmezi ụlọ nyocha gụnyere mbelata dị ukwuu na ọkwa AchRAb na mkpokọta ọnụọgụ B-lymphocyte, yana ọnụọgụ ọbara kwụsiri ike, ọrụ imeju na akụrụ. N'ọgwụgwọ, e dekọrọ mmụba pụtara ìhè na akara Quantitative Myasthenia Gravis (QMG) na Activitys of Daily Living (ADL). Ihe mgbaàmà dịka diplopia, isi ike ihu, dysarthria, na ike ọgwụgwụ aka gosiri mkpebi ma ọ bụ mmụba dị ukwuu.
Nke a na-egosi ike mgbanwe nke ọgwụgwọ BIOOCUS Medical Group CD19/BCMA CAR-T abụọ nke nwere ebumnuche abụọ n'inweta nrụzigharị ahụike miri emi na uru ahụike bara uru na MG na-adịghị ike. A na-anabata ọgwụgwọ a nke ọma, na-enweghị CRS ma ọ bụ nsí akwara, ma na-ekwe nkwa maka mgbaghara ogologo oge ma na-ebelata mkpa maka mgbochi ahụ ike na-adịghị ala ala.