Tijaabo caafimaad oo ku saabsan daawaynta unug ee CAR-T ee bukaanada qaba BCMA/TACI-soo laabashada togan iyo/ama dhawrka myeloma refractory

Soo koobid Kooban:

Daraasad ku saabsan APRIL Daaweynta unugyada CAR-T loogu talagalay bukaanada qaba BCMA/TACI ee soo laabashada togan iyo/ama dhawrka myeloma refractory

Faahfaahin faahfaahsan:

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 tijaabada caafimaadka of similar foreign products. 36 patients will be enrolled. The primary objective is to explore safety; the main consideration is dose-related safety.

Shuruudaha

Shuruudaha ka mid noqoshada:

1. Histologically confirmed diagnosis of BCMA/TACI+ Meelo badan (MM)：
   1. Bukaanka qaba MM ee soo noqday ka dib daawaynta BCMA CAR-T; Ama MM oo leh tibaax BCMA/TACI togan;
   2. Dib u soo noqday ka dib wareejinta unugyada tarma ee hematopoietic;
   3. Kiisaska leh cudur hadhaaga ah oo soo noqnoqda;
   4. Dhaawac ka baxsan, oo ay adag tahay in lagu ciribtiro kiimoterabiga ama shucaaca.
2. Lab ama naag da'doodu u dhaxayso 18-75;
3. Wadarta bilirubin ≤ 51 umol/L, ALT iyo AST 3 jeer xadka sare ee caadiga ah, creatinine ≤ 176.8 umol/L;
4. Echocardiogram wuxuu muujinayaa jajabka ka saarista ventricular ventricle (LVEF) ≥50%;
5. Ma jiro caabuq firfircoon oo ku dhaca sambabada, qoyaanka oksijiinta dhiiga ee hawada gudaha waa ≥ 92%;
6. Qiyaasta wakhtiga badbaadada ≥ 3 bilood;
7. Heerka waxqabadka ECOG 0 ilaa 2;
8. Bukaanka ama mas'uuliyiinta sharciga ah ayaa iskaa wax u qabso ah si ay uga qaybqaataan daraasadda oo ay saxeexaan oggolaanshaha la wargeliyey.

Shuruudaha Ka-saarista:

Mawduucyada leh mid ka mid ah shuruudaha soo socda ee ka saarida uma ay banaanayn tijaabadan:

1. Taariikhda dhaawacyada craniocerebral, khalkhalka miyir-qabka, suuxdin, ischemia cerebrovascular, iyo cerebrovascular, cudurrada dhiigbaxa;
2. Electrocardiogram wuxuu muujinayaa dhexda QT oo dheer, cudurada wadnaha oo daran sida wadna xanuun daran waagii hore;
3. Haweenka uurka leh (ama nuujinaya);
4. Bukaanka qaba caabuqyo firfircoon oo daran (marka laga reebo caabuqa kaadi mareenka fudud iyo pharyngitis bakteeriyada);
5. Caabuqa firfircoon ee fayraska cagaarshow B ama fayraska cagaarshow C;
6. Daawaynta isku dhafka ah ee steroids habdhiska 2 toddobaad gudahood ka hor baaritaanka, marka laga reebo bukaanada dhawaan ama hadda qaata steroids haled;
7. Markii hore lagu daweeyay wax kasta oo unug CAR-T ah ama daawaynta unugyada kale ee hidde ahaan wax laga beddelay;
8. Creatinine> 2.5 mg/dl, ama ALT/AST> 3 jeer oo xadiga caadiga ah, ama bilirubin> 2.0 mg/dl;
9. Cudurada kale ee aan la xakamayn ee aan ku haboonayn tijaabadan;
10. Bukaanka qaba caabuqa HIV;
11. Xaalad kasta oo uu baaruhu aaminsan yahay waxay kordhin karaan halista bukaanka ama faragelinayaan natiijada daraasadda