A takaice dai:
Nazarin APRIL Kwayoyin CAR-T ga marasa lafiya tare da BCMA/TACI tabbatacce koma baya da/ko refractory mahara myeloma
Cikakken Bayani:
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory BCMA/TACI positive relapsed and/or refractory multiple myeloma. The selection of dose levels and the number of subjects are based on gwaji na asibiti of similar foreign products. 36 patients will be enrolled. The primary objective is to explore safety; the main consideration is dose-related safety.
sharudda
Ka'idodin Hadawa:
- An tabbatar da ganewar asali na BCMA/TACI+ Multi myeloma (MM):
- Marasa lafiya tare da MM waɗanda suka sake komawa bayan BCMA CAR-T far; Ko MM tare da tabbataccen magana na BCMA/TACI;
- Maimaitawa bayan dashen kwayar cutar hematopoietic;
- Matsaloli tare da sake dawowa tabbatacce kadan saura cuta;
- Rawar da ke da wuyar kawar da ita ta hanyar chemotherapy ko radiotherapy.
- Namiji ko mace masu shekaru 18-75;
- Jimlar bilirubin ≤ 51 umol/L, ALT da AST ≤ 3 sau na babba iyaka na al'ada, creatinine ≤ 176.8 umol/L;
- Echocardiogram yana nuna juzu'in fitarwa na ventricular hagu (LVEF) ≥50%;
- Babu kamuwa da cuta mai aiki a cikin huhu, jikewar oxygen na jini a cikin gida shine ≥ 92%;
- Ƙayyade lokacin rayuwa ≥ watanni 3;
- Matsayin aikin ECOG 0 zuwa 2;
- Marasa lafiya ko masu kula da su na doka sun ba da kansu don shiga cikin binciken kuma su sanya hannu kan sanarwar da aka sanar.
Ka'idojin keɓewa:
Abubuwan da ke da kowane ɗayan waɗannan sharuɗɗan keɓance masu zuwa ba su cancanci wannan gwaji ba:
- Tarihin raunin craniocerebral, damuwa mai hankali, farfaɗowa, ischemia cerebrovascular, da cerebrovascular, cututtuka na hemorrhagic;
- Electrocardiogram yana nuna tsawan lokaci QT, cututtukan zuciya mai tsanani kamar arrhythmia mai tsanani a baya;
- Mata masu ciki (ko masu shayarwa);
- Marasa lafiya tare da cututtuka masu tsanani (ban da kamuwa da cutar urinary mai sauƙi da pharyngitis na kwayan cuta);
- Kamuwa da cuta mai cutar hanta ko cutar hanta ta C;
- Jiyya na lokaci-lokaci tare da steroids na tsarin a cikin makonni 2 kafin a gwada, sai dai ga marasa lafiya kwanan nan ko a halin yanzu suna karɓa a cikin kwayoyin halitta;
- A baya ana bi da su tare da kowane samfurin tantanin halitta na CAR-T ko wasu hanyoyin maganin ƙwayoyin cuta na T cell;
- Creatinine> 2.5 mg / dl, ko ALT / AST> sau 3 na adadin al'ada, ko bilirubin> 2.0 mg / dl;
- Sauran cututtuka marasa kulawa waɗanda ba su dace da wannan gwaji ba;
- Marasa lafiya masu kamuwa da cutar HIV;
- Duk wani yanayi da mai binciken ya yi imani zai iya ƙara haɗarin marasa lafiya ko tsoma baki tare da sakamakon binciken
