IiMyeloma ezininzi (MM)-01

UkuBuyiswa okuLungileyo kweSigulana seMyeloma sasekhaya esineSigulana esine-CAR-T yoNyango ngaphandle kokunqongophala kokuchazwa kwe-BCMA

Isigulane esisetyhini esifunyanwe sinenqanaba le-IIA IgD-λ uhlobo lwe-myeloma emininzi kwi-2018 yafumana unyango lokuqala ikakhulu nge-bortezomib. Emva kwemijikelo emi-3, wafumana uxolelo olupheleleyo (CR). Ngo-Okthobha ka-2018, wenziwa i-autologous hematopoietic stem cell transplantation njengonyango lokudibanisa, elandelwa lunyango lolondolozo kunye nenalidomide. Ngo-Epreli ka-2020, isifo saphinda saphinda, kwaye uye wafumana imijikelo esi-7 yonyango lodidi lwesibini, nto leyo eyenza ukuba angasebenzi kakuhle. Ukusukela ngoDisemba ka-2020 ukuya ku-Epreli ka-2021, wafumana unyango lwechemotherapy ikakhulu nge-daratumumab, kodwa i-biopsy yomongo wethambo isabonisa i-21.763% yeeseli zeplasma ezinobungozi ze-monoclonal, ezineserum yasimahla yetsheyini yokukhanya λ kwi-1470 mg/L kunye nomchamo wasimahla wekhonkco λ ku-5330 mg/L. Ngeli xesha, wayesele egqibile unyango olukumgangatho ophezulu kunye nonyango olukhoyo olufumaneka ekhaya, kubandakanywa utyando lwe-autologous stem cell, nokungena kulingo lwezonyango lwe-CAR-T ibe yeyona ndlela ilungileyo eseleyo.

Ethunyelwe ngoogqirha basekhaya, uye wanikezela kwisibhedlele saseLudaopei ngoMeyi 10, 2021, ngethemba lokubhalisa kulingo lwabo lwezonyango lwe-BCMA CAR-T unyango kwi-myeloma emininzi (MM). Akuba engeniswe, wayekwimeko ebuthathaka eneentlungu eziqhelekileyo kunye nefiva ephindaphindiweyo. Iimviwo ezibanzi ziqinisekisile "i-myeloma eninzi, i-λ chain chain type, i-ISS isigaba III, i-R-ISS isigaba se-III, iqela elinobungozi obuphezulu be-mSMART."

Iskena se-PET-CT sibonakalise ukonyuka kokwenziwa kwemetabolism kuxinaniso lwezicubu ezithambileyo ngaphakathi kwimingxuma yomongo wethambo le-femurs kunye ne-tibias, ebonisa ukubandakanyeka kwethumba. I-Bone marrow biopsy ibonise i-60.13% yeeseli ezinobungozi ze-plasma ze-monoclonal ngaphandle kokubonakaliswa kwe-BCMA.

Isibhedlele saseLudaopei sazisa isigulana kunye nosapho lwaso malunga nokusebenza konyango lwangoku lwe-BCMA-negative multiple myeloma, ethi nangona inokusebenza ngokoncwadi oluthile, ayinayo idatha ecacileyo. Emva kokuqwalaselwa ngenyameko, umguli nentsapho yaso bakhetha ukuqhubeka nesicwangciso sonyango.

Ukulandela imeko yangaphambili ngerejimeni yeFC, iiseli ze-BCMA CAR-T zafakwa nge-1 kaJuni, 2021, kwisibhedlele saseLudaopei. Isigulana siphuhlise umkhuhlane emva kokufakwa, okuye kwalawulwa ngokuthe ngcembe ngonyango olunamandla oluchasene ne-infective kunye neempawu ezixhasayo. Kwiintsuku ezilishumi elinesine emva kokufakwa, i-biopsy yomongo wamathambo ayizange ibonise iiseli zeplasma ze-monoclonal ezishiyekileyo. Kwiintsuku ezingamashumi amathathu ananye emva kokufakwa, i-biopsy yomongo yahlala ingenayo. I-Serum immunofixation yayingalunganga, i-serum free light chain λ yayiphakathi koluhlu oluqhelekileyo, kunye neprotheni ye-serum M yayingalunganga, ebonisa ukuxolelwa okupheleleyo kwesi sifo.

Okwangoku, ngaphezu kweenyanga ze-8 emva kokufumana i-BCMA CAR-T i-cell infusion, isigulane sihlala sixolelwe ngokupheleleyo ngokubuyiswa kakuhle kunye nokwaneliseka okuphezulu kwisiphumo sonyango.