Maris 2023:
Nau'in Nazari: Tsangwama (Gwajin Jiyya)
Ƙimar Yin rajista: Mahalarta 30
Rarraba: N/A
Samfurin Tsagaitawa: Tsayawa Tsayi
Siffar Model Intervention: Ana amfani da ƙirar "3+3" don ƙayyade Matsakaicin Jurewa (MTD) da shawarar kashi 2 na shawarar (RP2D)
Masking: Babu (Bude Label)
Manufar Farko: Jiyya
Taken Hukuma: Buɗe, Hannu Guda, Nazari Na Farko na 1 don Ƙimar Aminci/Ingantacciyar Farko da Ƙayyade Matsakaicin Jure Jure na B7-H3-Targeting CAR-T Cell Therapy a cikin Magance Maimaituwar Glioblastomas
Ainihin Ranar Fara Karatu: Janairu 27, 2022
Ƙididdigar Ƙarshen Ƙarshen Farko: Disamba 31, 2024
Ƙididdigar Ƙirar Ƙarshen Nazarin : Disamba 31, 2024
Matsayin haɓaka kashi:
Ana amfani da ƙirar haɓaka kashi na "3+3" don ƙayyade MTD & R2PD. Anti-B7-H3 autologous Kwayoyin CAR-T an ba marasa lafiya biweekly a waɗannan allurai na kowane zagayowar, da kuma hawan keke 4 a matsayin kwas ɗaya. Kashi na 1: marasa lafiya 3 a kashi na miliyan 20 Kwayoyin ga kowane zagayowar. Kashi na 2: marasa lafiya 3 a kashi na miliyan 60 Kwayoyin ga kowane zagayowar. Kashi na 3: marasa lafiya 3 a kashi na miliyan 150 Kwayoyin ga kowane zagayowar. Kashi na 4: marasa lafiya 3 a kashi na miliyan 450 Kwayoyin ga kowane zagayowar. Kashi na 5: marasa lafiya 3 a kashi na miliyan 900 Kwayoyin ga kowane zagayowar.
Lokacin tabbatarwa na R2PD:
Ƙayyade R2PD dangane da sakamakon da aka samu daga binciken da aka yi a baya-tsaro; Kula da wasu marasa lafiya 12 tare da anti-B7-H3 autologous Kwayoyin CAR-T kowane mako a R2PD don ƙara tabbatar da amincin R2PD.
A kowane kashi kashi, idan marasa lafiya sun nuna haƙuri da amsa ga magani, waɗannan marasa lafiya za su sami darussa da yawa na magani bisa ga PI.
sharudda
Ka'idodin haɗawa
- Namiji ko mace, masu shekaru 18-75 (ciki har da masu shekaru 18 da 75)
- Marasa lafiya tare da sake dawowa glioblastoma, kamar yadda aka tabbatar ta hanyar positron emission tomography (PET) ko ilimin ilimin tarihi.
- A >= 30% staining extent of B7-H3 in his/her primary/recurrent tumo tissue by the immunochemical method;
- Karnofsky ma'aunin ma'auni>=50
- Samuwar a cikin tattara sel mononuclear jini na gefe (PBMCs)
- isassun darajar dakin gwaje-gwaje da isassun aikin gabobin jiki;
- Marasa lafiya masu yuwuwar haifuwa/haihuwa dole ne su yarda suyi amfani da maganin hana haihuwa mai inganci sosai.
Ka'idodi na warewa
- Mata masu ciki ko masu shayarwa
- Contraindication to bevacizumab
- A cikin kwanaki 5 kafin jiko cell CAR-T, batutuwa masu karɓar tsarin tsarin tsarin steroids tare da sashi fiye da 10mg/d prednisone ko daidai allurai na sauran steroids (ba tare da inhaled corticosteroid ba)
- Haɗuwa tare da Wasu malignancies marasa sarrafawa
- Kwayar cutar rashin ƙarfi mai aiki (HIV), cutar hanta ta B, cutar hanta ta C ko kamuwa da cutar tarin fuka;
- Subjects receiving the placement of a carmustine slow-release wafer within 6 months before the enrollment;
- Cututtukan autoimmune;
- Samun maganin rigakafi na dogon lokaci bayan dashen gabobin jiki;
- Cututtuka masu tsanani ko rashin kulawa da tabin hankali ko yanayin da zai iya haɓaka mummunan al'amura ko tsoma baki wajen kimanta sakamakon;
- Ba a dawo da su daga abubuwan da suka shafi guba ko lahani ta hanyar magani na baya ba;
- Batutuwan da suka shiga cikin sauran gwajin shiga tsakani a cikin wata guda kafin yin rajista, ko kuma sun karɓi wasu hanyoyin kwantar da ƙwayoyin ƙwayoyin cuta na CAR-T ko maganin ƙwayoyin halitta da aka gyara kafin yin rajista.
- Batutuwa tare da yanayin likita waɗanda ke shafar sanya hannu a rubuce-rubucen yarda ko bin hanyoyin bincike, gami da, amma ba'a iyakance ga, cututtuka na jijiyoyin bugun jini na zuciya-cerebral, rashin aikin koda / gazawar, cututtukan huhu, rikicewar coagulation, kamuwa da cuta na tsarin aiki, kamuwa da cuta mara sarrafawa, da sauransu. . al., ko marasa lafiya waɗanda ba sa son ko ba su iya bin hanyoyin bincike;
- Abubuwan da ke da wasu sharuɗɗa waɗanda zasu tsoma baki tare da halartar gwaji bisa ga ra'ayin mai binciken.
