Fabrairu 2023: IASO Biotherapeutics 'binciken CAR T-cell far don sake dawowa ko refractory multiple myeloma (RRMM), CT103A, ya sami saurin sauri da kuma sabunta magungunan ci-gaban jiyya daga Hukumar Abinci da Magunguna ta Amurka (FDA), a cewar kamfanin.
Waɗannan sunaye suna ƙara wa jiyya na shekarar da ta gabata jerin sunayen marayu na miyagun ƙwayoyi daga hukumar gudanarwa.
Waɗannan sunayen, waɗanda ke ba da tallafin kuɗi da na ka'ida, ana nufin su hanzarta haɓakar magunguna waɗanda ke da yuwuwar magance cututtuka masu haɗari, masu barazana ga rayuwa, ko cututtukan da ba a saba gani ba waɗanda a halin yanzu ba su da isassun magunguna.
"Yin amfani da bututun samfurin sa na zamani [da] haɗin gwiwar masana'antu da damar aikin asibiti, IASO na da niyyar isar da hanyoyin gyara, warkewa da araha waɗanda ke biyan buƙatun likitanci ga marasa lafiya a China da ma duniya baki ɗaya," in ji kamfanin a cikin sanarwar. .
Ana sa ran gwajin CT103A na Amurka a watan Mayu
Matsayin waƙa mai sauri yana ba ku damar yin bitar birgima kuma ku ga idan kun cancanci amincewa da sauri da bitar fifiko. Rolling review yana nufin cewa kamfani zai iya aikawa a cikin sassan aikace-aikacen tsari kamar yadda suke a shirye, maimakon jira har sai an gama dukkan sassan kafin hukumar ta iya duba aikace-aikacen.
Ingantacciyar yarda, wanda kuma ake kira “amincewa na sharadi,” ana ba da jiyya waɗanda samunsu nan take ya cika buƙatun likita da ba a cimma ba tukuna, muddin shaidar farko ta nuna cewa fa'idodin maganin sun fi haɗari.
Tare da ƙirar RMAT, zaku iya magana da FDA da wuri, sau da yawa, kuma kusa. A cikin yanayin haɓakar yarda, shaidar asibiti da ake buƙata don tabbatar da fa'idodin maganin da kuma samun cikakkiyar yarda na iya zuwa daga wasu maɓuɓɓuka ban da gwajin gwaji na asibiti na gargajiya, wanda yawanci yana adana lokaci da kuɗi.
Ya zuwa yanzu, an gwada CT103A a kan marasa lafiya na myeloma a China, inda aka yi la'akari da farfadowa na ci gaba kuma yanzu ana sake duba shi cikin sauri. A can, IASO da Innovent Biologics suna aiki tare don yin CT103A.
A cikin Disamba, FDA ta amince da aikace-aikacen IASO don sabon magani na bincike. Wannan yana nufin cewa ana iya amfani da CT103A a ciki gwaji na asibiti a Amurka
Gwajin asibiti na Phase 1b (NCT05698303) zai gwada maganin akan manya har 12 tare da RRMM don ganin yadda lafiya da tasiri yake. Za a yi nazarin ne a Cibiyar Ciwon daji ta MD Anderson a Jami'ar Texas a Houston, Texas. Ana sa ran farawa a watan Mayu.
Chimeric antigen receptor (CAR) T-cell far yana aiki ta hanyar sauƙaƙawa ga ƙwayoyin T-cell, waɗanda nau'in ƙwayoyin cuta ne waɗanda ke iya yaƙi da cutar kansa, ganowa da kai hari kan ƙwayoyin cutar kansa.
Tattara kwayoyin T-cell na majiyyaci da canza su a cikin dakin gwaje-gwaje don yin mai karɓa, ko CAR, wanda ke gane takamaiman sunadaran akan ƙwayoyin cutar kansa shine babban ra'ayi bayan wannan hanyar. Lokacin da aka mayar da waɗannan sel ɗin injiniyoyi a cikin jiki, yakamata su nemo su kashe ƙwayoyin cutar kansa ba tare da cutar da ƙwayoyin jikin lafiya ba.
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 hanyoyin kwantar da hankali that can make it hard to re-dose them if a person’s cancer comes back.
A wani gwaji na farko na matukin jirgi (ChiCTR1) a kasar Sin, an bai wa mutane 1800018137 masu dauke da cutar RRMM maganin. Bayan kimanin shekara guda, dukkansu sun sami amsa ga maganin. Kusan kashi uku cikin huɗu (18%) sun sami cikakkiyar amsa ko mafi kyau, wanda ke nufin cewa ƙari ya ɓace.
Har zuwa yau, IOSA's CAR T-cell far an gwada shi a China kawai
Bayan haka, an fara gwajin Phase 1/2 mai suna FUMANBA-1 (NCT05066646) a kasar Sin don gwada aminci da ingancin CT103A a cikin manya har 132 masu dauke da 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.
Tun daga ranar 21 ga Janairu, 2022, an yi amfani da CT103A don jinyar mutane 79, kuma matsakaicin lokacin bibiya ya kusan watanni 10.
Wadannan marasa lafiya sun riga sun kasance ta hanyar tsaka-tsakin layi na biyar na jiyya, wasu daga cikinsu sune magungunan rigakafi, masu hana proteasome, da masu hana CD38. Goma sha biyu (15.2%) daga cikinsu an riga an yi musu magani ba na ɗan adam ba na BCMA wanda aka yi niyya na CAR-T.
Bayan tsaka-tsakin kwanaki 16 na jiyya, sakamakon ya nuna cewa yawancin marasa lafiya (94.9%) suna da aƙalla amsawa. Wannan ya haɗa da 68.4% na marasa lafiya waɗanda ke da cikakkiyar amsa ko mafi kyau da 89.9% na marasa lafiya waɗanda ke da amsa mai kyau ko mafi kyau.
Mutane 90 da ke fama da cutar sankara, wani nau'in ciwon daji da ke tsiro a wajen kasusuwan kasusuwa, duk sun sami sauki daga maganin. Duk wadannan mutane sun sami sauki bayan an yi musu magani, kuma kashi XNUMX% na su sun samu sauki ko kuma gaba daya.
The response rate for the 12 people who had CAR T-cell far before was 75%, and 41.7% of those people had a complete response or better.
Daga cikin duka rukuni na marasa lafiya 79, 92.4% suma ba su da kyau ga ƙananan cututtuka, ko ƙananan ƙwayoyin ciwon daji waɗanda wasu lokuta za su iya zama bayan magani kuma su sa cutar ta dawo.
Bayanan martaba na aminci na CT103A yana da kyau kuma mai sauƙin ɗauka.
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 hanyoyin kwantar da hankali. But most of the time, these reactions were mild or moderate and lasted about five days.
Immune effector cell-Associated neurotoxicity syndrome, wani mummunan martani na rigakafi wanda ke shafar tsarin mai juyayi, an gani a cikin mutane biyu. Alamun su sun kasance masu laushi ko matsakaici kuma sun tafi.
Gabaɗaya, CT103A bai haifar da martani na rigakafi wanda ya saba wa jiyya ba, kodayake 16.5% na marasa lafiya sun gwada tabbatacce ga ƙwayoyin rigakafi akan CT103A.
A cikin gwaji na Phase 1 FUMANBA-2 (NCT05181501), har zuwa 20 sabbin bincike, ana gwada marasa lafiya da yawa myeloma masu haɗari don ganin ko CT103A zai iya taimaka musu.
