Maris 2023: Immune thrombocytopenia (ITP) cuta ce da ke haifar da sauƙi ko wuce gona da iri da zub da jini. Kimanin kashi biyu bisa uku na marasa lafiya sun sami gafara bayan / lokacin jiyya na farko. Duk da haka, ɗayan ɓangaren marasa lafiya ba zai iya samun rangwame mai ɗorewa ba ko ma rashin yarda da jiyya na farko. Waɗancan lokuta, waɗanda aka sani da sake dawowa / refractory Immune thrombocytopenia (R/R ITP), suna fuskantar nauyi mai nauyi na cuta wanda ke rage ingancin rayuwa. Yawancin ƙwayoyin cuta suna shiga cikin abin da ya faru na R/R ITP, kuma mafi mahimmancin ɗayan su shine lalatawar platelet na rigakafi ta hanyar rigakafi. Kamar yadda aka sani, sel platelet autoantibodies galibi ana ɓoye su ta ƙwayoyin plasma, musamman ƙwayoyin plasma na dogon lokaci. Masu bincike suna so su gano cewa BCMA CAR-T na iya taimaka wa marasa lafiya na R/R ITP su kara yawan adadin platelet, rage zubar jini da kuma adadin magunguna masu haɗuwa.
Gwaji: Anti-BCMA CAR T-kwayoyin jiko R/R ITP marasa lafiya za su karɓi jiko na autologous anti-BCMA CAR T-kwayoyin tare da jimlar 1.0-2.0 × 10e7/Kg. Marasa lafiya za su kasance masu biyo baya don watanni 6 bayan haka CAR T-cell therapy.
Halittu: autologous anti-BCMA chimeric antigen receptor T Kwayoyin
Lymphoadenodepletion chemotherapy tare da FC (fludarabine 30mg / m2 na 3 a jere kwanaki da cyclophosphamide 300mg / m2 na 3 a jere kwanaki) za a ba a rana -5, -4 da -3 kafin. CAR T-kwayoyin jiko. Jimlar 1.0-2.0 × 10e7/Kg autologous anti-BCMA CAR T-kwayoyin za a shigar da shi ta hanyar haɓaka kashi-kashi bayan ilimin chemotherapy na lymphoadenodepletion. Kashi na CAR T-kwayoyin ana ba da izinin daidaitawa gwargwadon tsananin ciwon sakin cytokine.
sharudda
Ka'idodin Hadawa:
- Refractory ITP da aka ayyana bisa ga ka'idojin yarjejeniya na baya-bayan nan ('Jagorancin Sinawa game da ganewar asali da gudanar da thrombocytopenia na rigakafi na farko (version 2020)'), ko sake dawowa ITP wanda aka ayyana azaman marasa lafiya na ITP waɗanda suka amsa maganin farko (glucocorticoids ko immunoglobulins) da anti-CD20 monoclonal antibody, amma ba zai iya kula da amsa ba.
- Shekaru 18-65 sun haɗa da.
- Isasshen venous damar ga apheresis ko venous jini da kuma babu wasu contraindications ga leukocytosis.
- Matsayin aikin 0-2 na Gabashin Haɗin gwiwar Oncology Group (ECOG).
- Maudu'ai yakamata su kasance da cikakken iya aiki na farar hula, fahimtar mahimman bayanai, sanya hannu kan takardar izinin da aka sanar da son rai, kuma suna da kyakkyawan kamfani tare da abun ciki na wannan ka'idar bincike.
Ka'idojin keɓewa:
- ITP na biyu.
- Marasa lafiya da sanannen tarihi ko kafin ganewar asali na thrombosis na jijiya (irin su thrombosis na cerebral, infarction myocardial, da dai sauransu). na fitina.
- Marasa lafiya da sanannen tarihi ko kafin ganewar asali na mummunan cututtukan zuciya.
- Marasa lafiya tare da kamuwa da cuta mara sarrafawa, tabarbarewar gabobin jiki ko duk wata cuta mai aiki mara kulawa wacce zata hana shiga kamar yadda aka tsara.
- Marasa lafiya tare da malignancy ko tarihin malignancy.
- Gwajin faɗaɗawar salula T ya gaza.
- Yayin da ake nunawa, haemoglobin <100g/L; cikakkiyar ƙimar neutrophils <1.5×10^9/L.
- A lokacin nunawa, ƙwayar creatinine na jini> 1.5x na babba na kewayon al'ada, jimlar bilirubin> 1.5x babban iyaka na al'ada, alanine aminotransferase da aspartate aminotransferase> 3x babba iyaka na al'ada kewayon, Hagu ventricular ejection juzu'i ≤ 50%.
- Lokacin prothrombin (PT) ko prothrombin lokaci-ƙasa na al'ada rabo (PT-INR) ko lokacin thromboplastin da aka kunna (APTT) wanda ya wuce 20% na kewayon tunani na al'ada; ko tarihin rashin daidaituwa na coagulation banda ITP.
- Ko dai maganin rigakafi na HIV ko syphilis antibody yana da kyau; ciwon hanta na C yana da inganci kuma gano HCV-RNA ya wuce iyakar gwajin gwaji na sama; Hepatitis B surface antigen yana da inganci kuma gano HBV-DNA ya wuce iyakar gwajin gwaji na sama.
- Ya shiga cikin wasu nazarin asibiti a cikin watanni 3 kafin wannan jiko na CAR-T.
- Marasa lafiya suna da juna biyu ko suna shayarwa, ko shirin daukar ciki.
- Marasa lafiya suna da haihuwa kuma mai binciken ya yanke hukunci cewa shari'ar bai dace a shiga ba.
- Tarihin rashin lafiyar miyagun ƙwayoyi mai tsanani ko sanannen rashin lafiyar magungunan CAR-T masu alaƙa.
- Wanda ake zargi ko kafa barasa, muggan kwayoyi ko shaye-shayen kwayoyi.
- Mai binciken ya yanke hukuncin cewa bai dace a shiga wannan shari'ar ba.
