Iindidi zonyango

Unyango oluPhambili

Unyango lwe-Oncolytic Virus: Unyango lomhlaza oluPhambili

I-CAR-T yeGlioblastoma

I-Nusinersen Sodium Injection: Ithemba Lokuwohloka Kwemisipha Yomthambo

Unyango lwe-CAR-T lomhlaza wesisu

$Unyango lwe-CAR-T lwe-Relapsed/Refractory Neuroblastoma$

Unyango lwe-CAR-T lwe-Relapsed/Refractory Neuroblastoma

I-CAR-T yeSystemic Lupus Erythematosus (SLE)

Isifo seSickle Cell kunye neThalassemia

Unyango lweZini ezintsha lubonelela ngethemba elitsha kwizigulane ezineSickle Cell kunye neThalassemia

I-FUCASO: Unyango lwe-BCMA CAR-T oluGuqukileyo oluSebenza ngokuPheleleyo kunye noKhuseleko olungenakuthelekiswa nanto

Ukusebenzisa iiSeli ze-NK: Ukuphucula Unyango Lomhlaza Ngaphandle Kwemida

0102030405

Inkcazelo Epheleleyo Yonyango Oluqhekezayo Lwe-Leukemia

I-CAR-T Therapy, isifinyezo segama elithi Chimeric Antigen Receptor T-Cell Immunotherapy, yindlela yonyango oluphucukileyo lwezakhi zofuzo equka ukuguqula izakhi zofuzo zeeseli ze-T zesigulana ukuze zijolise kwaye zitshabalalise iiseli zomhlaza. Ngokungafaniyo namayeza emveli, unyango lwe-CAR-T lulungiselelwe isigulana ngasinye kwaye lufuna ukuqokelela iiseli ze-T egazini lesigulana ngaphambi kokuba ziphinde zifakwe emzimbeni emva kobunjineli bezakhi zofuzo.

Qhagamshelana nathi

Iimpawu ze-CAR-T

● I-B-cell acute lymphoblastic leukemia

●I-myeloma eninzi

●I-leukemia engapheliyo ye-lymphocytic

●I-lymphoma engeyiyo iHodgkin

●Ukusasaza i-lymphoma enkulu ye-B-cell

●I-SLE (i-Systemic Lupus Erythematosus)

●I-Myasthenia gravis

●Ezinye izifo ezihlasela umzimba

Ukusebenza kakuhle kweklinikhi ye-CAR-T

Iimpawu zeCD19+20CAR-T: Izigulane ezine-B-cell non-Hodgkin's lymphoma

Izinga le-CR lenyanga enye	Izinga le-PR lenyanga enye	Inyanga enye okanye izinga le-OR	I-CRS≥3	I-CRES≥3
71.95% (59/82)	25.6 (21/82)	97.55（80/82）	12.19% (10/82)	0

Iimpawu ze-CD19+22CAR-T: Unyango lwe-CD19 ephinde yabuyela kwi-CD19 kwaye izigulane ezine-B-lymphocytic leukemia ezinesifo esingapheliyo

Izinga le-CR lenyanga enye	Izinga le-PR lenyanga enye	Inyanga enye okanye izinga le-OR	I-CRS≥3	I-CRES≥3
92.1% (35/38)	7.9%（3/38）	100% （38/38）	15.79% (6/38)	0

Iimpawu ze-BCMACAR-T: Unyango lwe-myeloma ephindaphindayo nengasasebenziyo

Izinga le-CR lenyanga enye	Izinga le-PR lenyanga enye	Inyanga enye okanye izinga le-OR	I-CRS≥3	I-CRES≥3
72.41% (21/29)	27.59%（8/29）	100% (29/29)	6.9% (2/29)	0

Iingenelo Zethu

● Unyango oluKhethekileyo: Unyango ngalunye lwe-CAR-T lwenzelwe isigulana, ukuqinisekisa iziphumo zonyango ezijolise kakhulu nezisebenzayo.

● Iinketho ezahlukeneyo zokuJolisa: Ngoluhlu olubanzi lwee-antigens ezijoliswe kuzo, kuquka i-CD7, i-CD19, i-CD20, i-CD22, kunye ne-BCMA, iimveliso zethu ze-CAR-T zibonelela ngeendlela ezahlukeneyo zokunyanga izifo ezahlukeneyo zegazi kunye nezifo zokuzikhusela komzimba.

● Impumelelo yeKlinikhi eqinisekisiweyo: Unyango lwethu lwe-CAR-T lubonakalise ukusebenza kakuhle kakhulu kwiimeko ezininzi zonyango, kunye namazinga okuxolelwa okumangalisayo kunye neeprofayili zokhuseleko, okuqinisa isikhundla sethu njengenkokeli kunyango lwe-immunotherapy.

● Ukusebenza kakuhle kweendleko eziphezulu: Sinikezela ngomgangatho okhuphisanayo kunye nonyango olusemgangathweni ophezulu ngamaxabiso afikelelekayo xa kuthelekiswa nezinye iimveliso zeCAR-T ezikwimarike.

● Itekhnoloji yoBuchule: Sisebenzisa inkqubela phambili yamva nje kubunjineli bemfuza, unyango lwethu lwe-CAR-T luquka ikamva lomhlaza kunye nonyango lwezifo ezizikhuselayo emzimbeni.

● Inkxaso yezonyango yeengcaliIqela lethu elinamava loogqirha kunye nabaphandi libonelela ngononophelo olupheleleyo ukusuka kwingxoxo yokuqala ngokunikezelwa konyango kunye nokulandelela.

Iiseli ze-CAR-T ngoku ziyaqatshelwa ngokubanzi ngokusebenza kwazo kwizigulana ezingakhange zisabele kunyango lwendabuko olufana ne-chemotherapy okanye ukufakelwa komongo wethambo. Uluntu lwezonyango lwehlabathi luyavuma amandla amakhulu onyango lwe-CAR-T ekuguquleni iziphumo zezigulana.

Izifundo kunye namatyala anxulumene nonyango lwe-CAR-T

1. Unyango lwe-CAR-T lwe-Systemic Lupus Erythematosus: Ukusebenza Okumangalisayo Kwimeko Yabantwana

Ityala elibalulekileyo kwiSibhedlele saseYunivesithi yase-Erlangen libonise ukusebenza kakuhle konyango lweeseli ze-CAR-T ekunyangeni intombazana eneminyaka eli-15 ubudala ene-systemic lupus erythematosus (SLE). Emva kothotho lonyango olungaphumelelanga, u-Uresa wafumana olu nyango lutsha ngoJuni 2023. Kwiiveki ezintathu emva konyango, iimpawu zakhe zaziphucuke kakhulu, nto leyo ekhokelele ekubuyiselweni ngokupheleleyo nasekubuyiselweni komsebenzi wezintso. Le mpumelelo iphawula ukusetyenziswa kokuqala konyango lwe-CAR-T kwizifo zokuzikhusela kwabantwana, ibonisa amandla ayo okufezekisa ukuxolelwa kwexesha elide kunye nokuguqula iziphumo zesigulana. Uphando olongezelelweyo luyaqhubeka ukuze kuhlolwe ukusetyenziswa kwalo kwiimeko ezifanayo.

https://www.bioocus.com/news/breakthrough-in-pediatric-autoimmune-disease-car-t-cell-therapy-cures-lupus-patient/

2. Unyango lwe-CAR-T lweMultiple Myeloma: Uxolelo Olubalulekileyo Lufezekisiwe

UBjørn Simensen, isigulana esineminyaka engama-67 ubudala esivela eNorway, ufumene utshintsho olukhulu kumlo wakhe nxamnye ne-multiple myeloma (IgG lambda, ISS-II) emva kokufumana unyango lweeseli zeCAR-T. Ekuqaleni wafunyaniswa ukuba une-chemotherapy regimen ezininzi, kodwa waphinda wabuyela umva ngo-2021. Emva konyango olungasebenziyo, wathunyelwa kwiSibhedlele saseLu Daopei ngoFebruwari 2022, apho wakhethwa khona unyango lweCAR-T. Emva konyango olulungisiweyo, iiseli zakhe zeCAR-T zafakwa. Ngomhla wama-28, uhlolo lokulandelela lwabonisa ukuba akukho ziseli zeplasma ezingaqhelekanga kwithambo lakhe, nto leyo ebonisa impumelelo enkulu kunyango lwakhe.

https://www.bioocus.com/bj-rn-simensen-multiple-myeloma-igg-lambda-iss-ii-product/

Unyango lwe-3.CD7 CAR-T lwe-T-ALL ephinde yabuyela kwi-T kunye ne-LBL: Ukusebenza okuthembisayo kunye neziphumo

Uphando lwakutshanje lubonisa ukusebenza kakuhle konyango lwe-CD7 chimeric antigen receptor T-cell (CAR-T) oludityaniswe nokufakelwa kwesibini kwe-allogeneic hematopoietic stem cell (HSCT) kwizigulana ezine-relapse T-cell acute lymphoblastic leukemia (T-ALL) kunye ne-lymphoblastic lymphoma (LBL). Olu phando lwenziwe kwisibhedlele iHebei Yanda Lu Daopei, lubandakanye izigulana ezili-16 ezifumene i-100% minimal residue disease (MRD)-negative complete remission emva konyango. Nge-75% complete remission rate yezilonda ezingaphandle kwe-medullary kunye ne-1 year iyonke survival and leukemia-free survival rates of 58.5% and 51.4%, ngokulandelelana, le ndlela intsha inika ithemba elitsha lokuxolelwa kwexesha elide kwezi cancer zinamandla.

https://www.bioocus.com/news/promising-outcomes-of-cd7-car-t-therapy-combined-with-second-transplant-in-relapsed-t-all-lbl-patien/

4. Unyango lwe-CAR-T lwe-B-Cell Acute Lymphoblastic Leukemia: Ukusebenza Okungazange Kubonwe ngaphambili

Uphononongo lwakutshanje lubonisa ukusebenza kakuhle kakhulu konyango lwe-chimeric antigen receptor-T cell (CAR-T) ekunyangeni i-B-cell acute lymphoblastic leukemia (B-ALL). Olu phando lwenziwe ngentsebenziswano ne-BIOOCUS kunye neSibhedlele iLu Daopei, lubonise ukuba inani elikhulu lezigulana lifumene uxolelo olupheleleyo, libeka unyango lwe-CAR-T njengonyango oluphambili lwale leukemia inamandla. Iziphumo ezithembisayo zigxininisa amandla okuguqula unyango lwe-CAR-T kwi-oncology, zinika ithemba kwizigulana nakwiintsapho ezijongene ne-B-ALL. Njengoko uphando luqhubeka, unyango lwe-CAR-T luza kudlala indima ebalulekileyo kwixesha elizayo lonyango lomhlaza.

https://www.bioocus.com/news/pioneering-car-t-therapy-in-b-cell-acute-lymphoblastic-leukemia-shows-unprecedented-efficacy/

Inkqubo yoNyango lwe-CAR-T

Ingqokelela yeeSeli ze-T ezi-1:

Ekuqaleni, oogqirha baqokelela iiseli ze-T egazini lesigulana besebenzisa inkqubo ebizwa ngokuba yi-leukapheresis. Le nkqubo idla ngokuthatha malunga neeyure ezi-4, apho umhluzi wegazi uhlukanisa iiseli zegazi ezimhlophe ezifunekayo aze abuyisele ezinye izinto emzimbeni wesigulana.

2. Ukuguqulwa nokwandiswa kwemfuza:

Iiseli ze-T eziqokelelweyo zithunyelwa kwilebhu ukuze zilungiswe ngokwemfuza. Kweli nyathelo, iiseli ze-T zenzelwe ukujolisa nokutshabalalisa iiseli zomhlaza. Le nkqubo ithatha malunga neeveki ezi-2-3. Ngeli xesha, iiseli ze-T ziyavuselelwa kwaye zandiswe kwilebhu ukuqinisekisa ukusebenza kwazo ngokuchasene nomhlaza.

3. Ukufakwa kweeSeli:

Emva kokuba ii-T cells ezilungisiweyo zilungile, zibuyiselwa emzimbeni wesigulana ngokufakwa kwi-intravenous infusion. Eli nyathelo livumela ii-immune cells eziguquliweyo ukuba ziqaphele kwaye zisuse iiseli zomhlaza ngokufanelekileyo.

Izigulana zinokufumana iziphumo ebezingalindelekanga ngexesha lonyango, eyona ixhaphakileyo yi-cytokine release syndrome (CRS), ebangelwa yimpendulo yomzimba ngexesha lokutshatyalaliswa kweeseli zomhlaza ezisebenzayo. Nangona i-CRS inokuba yingozi kakhulu, ukuhambela phambili kunyango kuye kunciphisa kakhulu iingozi zayo.

Lonke umjikelo wonyango, ukusuka ekuqokeleleni iiseli ukuya ekufakweni, uhlala uthatha iiveki ezi-4-6, nangona ubude obuchanekileyo buxhomekeke kwimeko ethile yesigulana.

Inkxaso epheleleyo kwizigulana zamazwe ngamazwe eziya kwi-BIOOCUS ukuze zifumane unyango lwe-CAR-T

Apha kwi-BIOOCUS, sizinikele ekuboneleleni ngononophelo olukhethekileyo kunye nenkxaso kwizigulane zamazwe ngamazwe ezifuna unyango lwe-CAR-T. Iinkonzo zethu ezibanzi zigubungela lonke inyathelo lohambo, ukusuka kumalungiselelo angaphambi kohambo ukuya kunyango lwasemva konyango.

1. Ukulungiselela Ngaphambi Kohambo

Ngaphambi kokuba baye kwi-BIOOCUS, izigulana ziya kuhlolwa kwangaphambili ngokucokisekileyo kwiziko labo lezonyango lasekuhlaleni. Oku kuquka ukuphononongwa ngokucokisekileyo kwembali yezonyango, uhlolo lomzimba, kunye novavanyo olufanelekileyo olufana nomsebenzi wegazi, izifundo zomfanekiso, kunye nokuhlolwa okuthe ngqo kuhlobo lomhlaza olunyangwayo (njenge-leukemia, i-lymphoma, okanye eminye imidlaza yegazi). Siqinisekisa ukuba zonke iirekhodi zonyango, kuquka unyango lwangaphambili, iziphumo zovavanyo, kunye nokuqinisekiswa kokuxilongwa, zithunyelwa kwiqela lethu ukuze ziphononongwe kwaye zilungiselelwe.

2.Uhambo kunye nokulaliswa esibhedlele

Sinceda kuzo zonke iinkalo zokuhamba, kuquka ukulungiselela indawo yokuhlala kunye nokubhukisha izigulane ezilaliswayo kwi-BIOOCUS International Medical Center. Xa zifika, izigulane zikhokelwa kwinkqubo yokwamkelwa, ukuqinisekisa ukuba utshintsho oluhamba kakuhle kwindawo yonyango luyaqhubeka.

3. Inkqubo yoNyango

Emva kokungeniswa, izigulana ziya kuhlolwa uthotho lwangaphambi kokufumana unyango, kuquka uvavanyo lokuqinisekisa ukuba ziyafaneleka na ukufumana unyango lwe-CAR-T. Oku kuya kubandakanya ukuphononongwa kwesimo somhlaza sesigulana kunye nempilo iyonke, kunye nokuqokelelwa kwegazi ukuze kukhutshwe iiseli ze-T. Iiseli ze-T eziqokelelweyo emva koko zithunyelwa kwilebhu yethu eqinisekisiweyo yi-GMP ukuze ziguqulwe izakhi zofuzo. Le nkqubo inokuthatha malunga neeveki ezi-2-3.

4. Ukufakwa kweeSeli kunye noKhathalelo emva koNyango

Nje ukuba iiseli ze-CAR-T eziguquliweyo zilungile, izigulane ziya kubuyela esibhedlele sethu ukuze zifumane inkqubo yokufakwa. Olu lunyango oluqhutywa kube kanye apho iiseli ze-T ezenziwe ngobunjineli zifakwa ngemithambo yegazi. Emva kokufakwa, izigulane ziya kuhlala zijongiwe kangangeentsuku ezininzi ukuze zijonge iziphumo ebezingalindelekanga, ezifana ne-cytokine release syndrome, eyindlela enokwenzeka yokusabela kunyango. Iqela lethu lezonyango libonelela ngenkxaso eqhubekayo kunye nokubeka iliso ngeli xesha libalulekileyo.

Emva kokuphuma esibhedlele, i-BIOOCUS iququzelela utyelelo lokulandelela rhoqo, kuquka iimvavanyo zelebhu kunye nezifundo zokwenza imifanekiso, ukujonga ukusebenza kakuhle konyango kunye nokulandelela ukubuya kwesigulana. Izigulana ziya kuhlolwa ngokusondeleyo naziphi na iziphumo ezisemva konyango, kwaye iqela lethu liya kuhlala linxibelelana ukuze libonelele ngesikhokelo nenkxaso eqhubekayo.

Apha kwi-BIOOCUS, sibeka phambili impilo, ukhuseleko, kunye nentuthuzelo yezigulane zethu zamazwe ngamazwe. Injongo yethu kukubonelela ngononophelo olupheleleyo kunye nokuqinisekisa amava axhasayo nangenamthungo kulo lonke uhambo lonyango lwe-CAR-T.

Ukuze ufumane ulwazi oluthe kratya malunga neenkonzo zethu kunye nendlela esinokukunceda ngayo ngonyango lwakho, nceda unxibelelane nathi ngqo.

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