Febhuwari 2023: IASO Biotherapeutics’ investigational CAR T-cell therapy for relapsed or refractory multiple myeloma (RRMM), CT103A, has received fast track and regenerative medicine advanced therapy designations from the U.S. Food and Drug Administration (FDA), according to the firm.
Lezi zimpawu zengeza ekuqokweni kwezidakamizwa zentandane zokwelashwa zangonyaka odlule ezivela endikimbeni elawulayo.
Lokhu kuqokwa, okunikeza ukwesekwa kwezezimali nokulawula, kuhloselwe ukusheshisa ukwakhiwa kwezidakamizwa ezinamandla okwelapha izifo ezimbi kakhulu, ezibeka impilo engcupheni, noma ezingajwayelekile okukhona manje ukwelashwa okunganele.
"Ngokusebenzisa ipayipi layo lomkhiqizo omusha [kanye] namakhono adidiyelwe okwenziwa nawomtholampilo, i-IASO ihlose ukuletha izindlela zokwelapha eziguqukayo, ezelaphekayo nezithengekayo ezifeza izidingo zezokwelapha ezingahlangatshezwana neziguli zaseChina nasemhlabeni jikelele," inkampani isho esimemezelweni sayo. .
Isivivinyo sase-US se-CT103A silindeleke ngoMeyi
Isimo sokulandelela okusheshayo sikuvumela ukuthi udlule ekubuyekezeni isibuyekezo futhi ubone ukuthi uyakufanelekela yini ukugunyazwa ngokushesha kanye nokubuyekezwa okubalulekile. Ukubuyekezwa kwe-rolling kusho ukuthi inkampani ingathumela izingxenye zesicelo sokulawula njengoba sezilungile, esikhundleni sokulinda kuze kube yilapho zonke izingxenye zenziwe ngaphambi kokuba i-ejensi ibheke isicelo.
Ukugunyazwa okusheshisiwe, okubuye kubizwe ngokuthi “ukugunyazwa okunemibandela,” kunikezwa ekwelapheni ukutholakala kwakho ngokushesha kugcwalisa isidingo sezokwelapha esingakahlangatshezwa, inqobo nje uma ubufakazi bangaphambi kwesikhathi bubonisa ukuthi izinzuzo zokwelashwa zidlula izingozi.
Ngokuqokwa kwe-RMAT, ungakhuluma ne-FDA kusenesikhathi, ngokuvamile, futhi eduze. Esimeni sokugunyazwa okusheshisiwe, ubufakazi bomtholampilo obudingekayo ukuze kuqinisekiswe izinzuzo zokwelashwa nokuthola imvume egcwele kungase kuvele emithonjeni ngaphandle kokuhlolwa komtholampilo okuqinisekisayo okungokwesiko, okuvamise ukonga isikhathi nemali.
Kuze kube manje, i-CT103A isazanywe kuphela ezigulini ze-myeloma e-China, lapho yathathwa njengokwelapha okuyimpumelelo futhi manje isibuyekezwa ngokushesha. Lapho, i-IASO kanye ne-Innovent Biologics basebenzisana ukwenza i-CT103A.
NgoDisemba, i-FDA yagunyaza isicelo se-IASO somuthi omusha ophenywayo. Lokhu bekusho ukuthi i-CT103A ingasetshenziswa ku izivivinyo zokwelashwa e-US
Uhlolo lomtholampilo lweSigaba 1b (NCT05698303) luzohlola ukwelashwa kubantu abadala abangafika kwabayi-12 abane-RRMM ukuze babone ukuthi kuphephe futhi kusebenza kangakanani. Ucwaningo luzokwenziwa e-MD Anderson Cancer Centre eNyuvesi yaseTexas eHouston, eTexas. Kulindeleke ukuthi kuqale ngoMeyi.
I-Chimeric antigen receptor (CAR) I-T-cell therapy isebenza ngokwenza kube lula kuma-T-cell, okuwuhlobo lwamangqamuzana omzimba angakwazi ukulwa nomdlavuza, ukuthola nokuhlasela amangqamuzana omdlavuza.
Ukuqoqa ama-T-cell esiguli nokuwashintsha elebhu ukuze kwenziwe isamukeli, noma i-CAR, ebona amaprotheni athile kumaseli omdlavuza kuwumqondo oyinhloko wale ndlela. Lapho la mangqamuzana anjiniyela ebuyiselwa emzimbeni, kufanele athole futhi abulale amangqamuzana omdlavuza ngaphandle kokulimaza amangqamuzana anempilo omzimba.
CT103A goes after a protein called B-cell mature antigen that is only found in cancer cells (BCMA). It also has a small piece of a human antibody that is meant to lower the chance that the body’s immune system will attack the therapy. This is a common problem with CAR T-cell zokwelapha that can make it hard to re-dose them if a person’s cancer comes back.
Ocwaningweni lwangaphambi kwesikhathi lweSigaba 1 (ChiCTR1800018137) e-China, abantu abangu-18 abane-RRMM banikezwa ukwelashwa. Cishe ngemva konyaka, bonke baba nempendulo ekwelapheni. Cishe izingxenye ezintathu kwezine (72,2%) zinempendulo ephelele noma engcono, okusho ukuthi isimila sabo sasingasekho.
Kuze kube manje, ukwelashwa kwe-CAR T-cell ye-IOSA kuhlolwe e-China kuphela
Ngemva kwalokho, uhlolo lweSigaba 1/2 olubizwa nge-FUMANBA-1 (NCT05066646) lwaqalwa e-China ukuze kuhlolwe ukuphepha nokusebenza kwe-CT103A kubantu abadala abangafika kwabayi-132 abane-RRMM.
Last year, at the European Hematology Association Research Conference, a presentation was given called “Updated Phase 1/2 Data of the Safety and Efficacy of CT103A, Fully-Human BCMA-Directed CAR-T Cells in Relapsed/Refractory Multiple Myeloma.” This was based on data from the first two phases of the study.
Kusukela ngoJanuwari 21, 2022, i-CT103A yayisetshenziswe ukwelapha abantu abangama-79, futhi isikhathi esimaphakathi sokulandelela sasicishe sibe izinyanga eziyi-10.
Lezi ziguli zase zidlule emikhakheni emihlanu yokwelashwa, eminye yayo okwakuyimithi evimbela ukuzivikela komzimba, ama-proteasome inhibitors, nama-CD38 inhibitors. Abayishumi nambili (15.2%) babo base bevele belashwe nge-CAR-T cell therapy engahlosiwe ye-BCMA.
Ngemuva kwesilinganiso sezinsuku ze-16 zokwelashwa, imiphumela ibonise ukuthi iziguli eziningi (94.9%) zinempendulo okungenani ingxenye. Lokhu kufaka phakathi i-68.4% yeziguli ezibe nempendulo ephelele noma engcono kanye ne-89.9% yeziguli ezinempendulo enhle kakhulu ngokwengxenye noma engcono.
Abantu abayishumi abane- extramedullary myeloma, uhlobo lomdlavuza olukhula ngaphandle komnkantsha, bonke baba ngcono ekwelashweni. Bonke laba bantu baba ngcono ngemva kokwelashwa, futhi u-90% wabo waba ngcono noma waba ngcono ngokuphelele.
The response rate for the 12 people who had Ukwelashwa kwe-CAR T-cell before was 75%, and 41.7% of those people had a complete response or better.
Eqeqebeni eliphelele leziguli ezingama-79, ama-92.4% nawo ayengenalo isifo esincane esisele, noma inani elincane lamangqamuzana omdlavuza angasala ngezinye izikhathi ngemva kokwelashwa futhi abangele ukuthi lesi sifo sibuye.
Iphrofayili yokuphepha ye-CT103A yayiyinhle futhi kulula ukuyiphatha.
Most patients (94.9%) had cytokine release syndrome, which is an immune response that can be dangerous and is often seen with CAR T-cell zokwelapha. But most of the time, these reactions were mild or moderate and lasted about five days.
I-immune effector cell-associated neurotoxicity syndrome, impendulo engathi sína yamasosha omzimba ethinta isimiso sezinzwa, yabonwa kubantu ababili. Izimpawu zabo zazithambile noma zimaphakathi futhi zahamba.
Ngokuvamile, i-CT103A ayizange ibangele ukusabela kwamasosha omzimba okwakumelene nokwelashwa, nakuba u-16.5% weziguli wahlolwa wathola amasosha omzimba ngokumelene ne-CT103A.
Ocwaningweni lweSigaba 1 se-FUMANBA-2 (NCT05181501), kufika ku-20 iziguli ezisanda kutholwa, ezisengozini enkulu ye-myeloma eminingi ziyahlolwa ukuze kubonakale ukuthi i-CT103A ingazisiza yini.
