Mashi 2023: I-Immune thrombocytopenia (ITP) wukuphazamiseka okungaholela ekulimazeni okulula noma okudlulele nokopha. Cishe izingxenye ezimbili kwezintathu zeziguli zithola ukukhululeka ngemva/ngesikhathi sokwelashwa komugqa wokuqala. Kodwa-ke, enye ingxenye yeziguli ayikwazanga ukuzuza ukuthethelelwa okuhlala isikhathi eside noma ukuphikiswa ekwelashweni kokuqala. Lezo zimo, ezaziwa njenge-relapse/refractory Immune thrombocytopenia (R/R ITP), ziba nomthwalo osindayo wesifo owehlisa izinga lempilo. Ama-pathogenesis amaningi abamba iqhaza ekuveleni kwe-R/R ITP, futhi okubaluleke kakhulu kuwo ukubhujiswa kwe-antibody-mediated immune platelet. Ngokwazi kwayo, ama-autoantibodies e-platelet yomuntu akhiqizwa ikakhulukazi amaseli e-plasma, ikakhulukazi amaseli e-plasma aphila isikhathi eside. Abacwaningi bafuna ukuhlola ukuthi i-BCMA CAR-T ingasiza yini iziguli ze-R/R ITP ukwandisa inani leplatelet, zehlise iziqephu zokopha kanye nomthamo wemithi ehambisanayo.
Okokuhlola: I-Anti-BCMA CAR T-amaseli ukumnika iziguli ze-ITP ze-R/R zizokwamukela ukumiliselwa kwe-autologous anti-BCMA CAR T-amaseli ngesamba esingu-1.0-2.0×10e7/Kg. Iziguli zizolandelelwa ngemuva kwezinyanga eziyisi-6 I-CAR T-cell therapy.
I-Biological: i-autologous anti-BCMA Chimeric antigen receptor T amaseli
I-Lymphoadenodepletion chemotherapy nge-FC (i-fludarabine 30mg/ m2 izinsuku ezingu-3 ezilandelanayo kanye ne-cyclophosphamide 300mg/m2 izinsuku ezingu-3 ezilandelanayo) izonikezwa ngosuku -5, -4 no-3 ngaphambi CAR T-amaseli ukumnika. Isamba esingu-1.0-2.0×10e7/Kg anti-BCMA esizenzakalelayo CAR T-amaseli izofakwa ngokukhuphuka komthamo ngemuva kwe-lymphoadenodepletion chemotherapy. Umthamo we I-CAR T-amaseli are allowed to be adjusted according to the severity of i-cytokine release syndrome.
Imigomo
Imigomo Yokufaka:
- I-ITP ye-Refractory ichazwe ngokwemibandela yakamuva yokuvunyelwana ('isiqondiso saseShayina ekuxilongeni nasekuphathweni kwe-immune immune thrombocytopenia (inguqulo 2020)'), noma i-ITP ephindayo echazwa njengeziguli ze-ITP eziphendule ekwelashweni komugqa wokuqala (glucocorticoids noma ama-immunoglobulins) kanye ne-anti-CD20 monoclonal antibody, kodwa ayikwazi ukugcina impendulo.
- Iminyaka engu-18-65 ihlanganisiwe.
- Ukufinyelela kwe-venous okwanele kwe-apheresis noma igazi le-venous futhi akukho okunye ukuphikisana kwe-leukocytosis.
- Isimo sokusebenza se-Eastern Cooperative Oncology Group (ECOG) sokungu-0-2.
- Izifundo kufanele zibe nomthamo ogcwele wokuziphatha komphakathi, ziqonde ulwazi oludingekayo, zisayine ifomu lemvume enolwazi ngokuzithandela, futhi zibe nenhlangano enhle nokuqukethwe yile phrothokholi yocwaningo.
Imigomo Yokukhishwa:
- I-ITP yesibili.
- Iziguli ezinomlando owaziwayo noma ukuxilongwa kwangaphambilini kwe-arterial thrombosis (njenge-cerebral thrombosis, i-myocardial infarction, njll.), noma i-comorbidity ye-venous thrombosis (njenge-deep vein thrombosis, i-pulmonary embolism), noma zisebenzisa i-anticoagulant/antiplatelet drug ekuqaleni. kwecala.
- Iziguli ezinomlando owaziwayo noma ukuxilongwa kwangaphambilini kwesifo esibucayi senhliziyo nemithambo yegazi.
- Iziguli ezinokutheleleka okungalawuleki, ukungasebenzi kwezitho zomzimba noma noma yikuphi ukuphazamiseka kwezokwelapha okungalawuleki okungavimbela ukubamba iqhaza njengoba kuchaziwe.
- Iziguli ezinobubi noma umlando wobubi.
- Ukuhlolwa kwe-T cell kwehlulekile.
- Ngesikhathi sokuhlolwa, i-hemoglobin <100g/L; inani eliphelele lesibalo se-neutrophil <1.5×10^9/L.
- Ngesikhathi sokuhlolwa, ukuhlushwa kwe-serum creatinine> 1.5x umkhawulo ophezulu webanga elivamile, isamba se-bilirubin> 1.5x umkhawulo ophezulu webanga elivamile, i-alanine aminotransferase kanye ne-aspartate aminotransferase> 3x umkhawulo ophezulu webanga elivamile, ingxenyena yokukhipha i-ventricular ≤ I-50% nge-echocardiography, umsebenzi we-Pulmonary ≥ grade 1 dyspnea (CTCAE v5.0), i-blood oxygen saturation <91% ngaphandle kokuphefumula kwe-oxygen.
- Isikhathi se-Prothrombin (PT) noma isilinganiso se-prothrombin sesikhathi samazwe ngamazwe esijwayelekile (PT-INR) noma isikhathi se-thromboplastin esiyingxenye esicushiwe (APTT) esidlula u-20% webanga elijwayelekile lereferensi; noma umlando wokungajwayelekile kwe-coagulation ngaphandle kwe-ITP.
- I-antibody ye-HIV noma i-syphilis antibody ine-positive; I-antibody ye-hepatitis C ilungile futhi ukutholwa kwe-HCV-RNA kudlula umkhawulo wereferensi yokuhlolwa kwaselabhorethri; I-antigen ye-hepatitis B ebusweni ilungile futhi ukutholwa kwe-HBV-DNA kweqa umkhawulo wereferensi wokuhlolwa kwaselabhorethri.
- Ibambe iqhaza kwezinye izifundo zomtholampilo phakathi nezinyanga ezi-3 ngaphambi kwalokhu kufakwa kweseli ye-CAR-T.
- Iziguli zikhulelwe noma zincelisa, noma zihlela ukukhulelwa.
- Iziguli zivundile futhi umphenyi unquma ukuthi icala alifanelekile ukubamba iqhaza.
- Umlando wokungezwani nezidakamizwa okunzima noma ukwaliwa okwaziwayo emithini ehlobene nokwelashwa kwe-CAR-T.
- Ukusetshenziswa kabi kotshwala okusolwayo noma okusunguliwe, izidakamizwa noma izidakamizwa.
- Umseshi uyahlulela ukuthi akufanelekile ukuhlanganyela kuleli cala.
