Febraayo 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.
Magacyadani waxay ku darayaan daawaynta sanadkii hore ee agoonta magacaabista daroogada ee ka timid hay'adda sharciyeynta.
Magacyadan, kuwaas oo bixiya taageero maaliyadeed iyo sharci, waxaa loola jeedaa in lagu dedejiyo soo saarista dawooyinka awoodda u leh in lagu daweeyo cudurrada halista ah, nafta halis geliya, ama aan caadi ahayn oo ay hadda jiraan daaweyn ku filan.
"Iyada oo ka faa'iidaysanaysa… .
Tijaabada Maraykanka ee CT103A ayaa la filayaa bisha Maajo
Heerka orodka degdega ah wuxuu kuu ogolaanayaa inaad dhex marto dib u eegis oo arag haddii aad u qalanto oggolaanshaha degdega ah iyo dib u eegista mudnaanta leh. Dib-u-eegistu waxay ka dhigan tahay in shirkaddu ay u diri karto qaybo ka mid ah codsiga sharciyeynta markay diyaar yihiin, halkii ay sugi lahaayeen ilaa dhammaan qaybaha la dhammeeyo ka hor intaysan wakaaladu eegin codsiga.
Oggolaanshaha degdega ah, oo sidoo kale loo yaqaan "ogolaanshaha shuruuda," ayaa la siiyaa daawaynta kuwaas oo helitaankooda degdega ah ay buuxinayaan baahi caafimaad oo aan weli la daboolin, ilaa iyo inta caddaynta hore ay muujinayso in faa'iidooyinka daawadu ay ka miisaan badan yihiin khatarta.
Magacaabista RMAT, waxaad la hadli kartaa FDA waqti hore, badanaa, iyo meel dhow. Xaaladda ogolaanshaha la dedejiyey, caddaynta bukaan-socodka ee loo baahan yahay si loo xaqiijiyo faa'iidooyinka daaweynta iyo helitaanka oggolaansho buuxda ayaa laga yaabaa inay ka yimaadaan ilo aan ahayn tijaabada caafimaad ee xaqiijinta ee dhaqameed, taas oo badiyaa badbaadisa waqti iyo lacag.
Ilaa hadda, CT103A ayaa kaliya lagu tijaabiyay bukaanada myeloma ee Shiinaha, halkaas oo loo arkayay daaweyn horumar leh oo hadda si dhakhso ah dib loogu eegayo. Halkaa, IASO iyo Innovent Biologics waxay ka wada shaqaynayaan samaynta CT103A.
Bishii Disembar, FDA waxay ansixisay IASO codsigeeda baaritaanka dawooyinka cusub. Tani waxay ka dhigan tahay in CT103A loo isticmaali karo tijaabada caafimaadka ee Maraykanka
Tijaabada caafimaad ee Wajiga 1b (NCT05698303) waxay daawaynta ku tijaabin doontaa ilaa 12 qof oo qaangaar ah oo qaba RRMM si loo arko sida ay badbaado iyo waxtar u leedahay. Daraasadda waxaa lagu sameyn doonaa Xarunta MD Anderson Cancer Center ee Jaamacadda Texas ee Houston, Texas. Waxaa la filayaa inay bilaabato bisha May.
Chimeric antigen reseptor (CAR) T-cell therapy waxay u shaqeysaa iyadoo u sahlaysa unugyada T-cell, kuwaas oo ah nooca unugyada difaaca ee la dagaallami kara kansarka, inay helaan oo weeraraan unugyada kansarka.
Uruurinta unugyada T- bukaanka oo lagu beddelo shaybaarka si loo sameeyo reseptor, ama CAR, oo aqoonsan borotiinno gaar ah oo ku jira unugyada kansarka ayaa ah fikradda ugu weyn ee ka dambeysa habkan. Marka unugyadan la farsameeyay dib loogu celiyo jidhka, waa in ay helaan oo ay dilaan unugyada kansarka iyaga oo aan waxyeello u geysan unugyada caafimaadka qaba ee jidhka.
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 daawaynta that can make it hard to re-dose them if a person’s cancer comes back.
Tijaabadii hore ee tijaabada Wajiga 1 (ChiCTR1800018137) ee Shiinaha, 18 qof oo qaba RRMM ayaa la siiyay daawaynta. Qiyaastii hal sano ka dib, dhamaantood waxay heleen jawaab celin daawaynta. Ku dhawaad saddex-meelood meel (72,2%) waxay heleen jawaab celin dhamaystiran ama ka sii fiican, taas oo macnaheedu yahay in burodoodii ay tagtay.
Ilaa taariikhda, IOSA's CAR T-therapy therapy kaliya ayaa lagu tijaabiyay Shiinaha
Intaa ka dib, tijaabada Wajiga 1/2 ee loo yaqaan FUMANBA-1 (NCT05066646) ayaa laga bilaabay Shiinaha si loo tijaabiyo badbaadada iyo waxtarka CT103A ilaa 132 qaangaar ah oo qaba 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.
Laga bilaabo Janaayo 21, 2022, CT103A waxaa loo isticmaalay in lagu daweeyo 79 qof, celceliska waqtiga dabagalkuna wuxuu ku dhawaaday 10 bilood.
Bukaannadani waxay horey u soo mareen dhexdhexaad shan xariiq oo daaweyn ah, kuwaas oo qaarkood ay ahaayeen dawooyinka difaaca jirka, proteasome inhibitors, iyo CD38 inhibitors. Laba iyo toban (15.2%) ka mid ah ayaa mar hore lagu daweeyay daawaynta unugga CAR-T ee aan bini'aadmi ahayn ee BCMA-da.
Ka dib dhexdhexaad ah 16 maalmood oo daaweyn ah, natiijadu waxay muujisay in bukaanada intooda badan (94.9%) ay heleen ugu yaraan jawaab celin qayb ah. Tan waxaa ku jiray 68.4% bukaanada helay jawaab celin dhamaystiran ama ka wanaagsan iyo 89.9% bukaanada helay jawaab qaybeed aad u wanaagsan ama ka wanaagsan.
Toban qof oo qaba myeloma extramedullary, oo ah nooca kansar ka soo baxa meel ka baxsan dhuuxa lafta, ayaa dhammaantood ka roonaaday daawaynta. Dhammaan dadkan ayaa ka roonaaday daawaynta ka dib, 90% ka mid ahina way fiicnaadeen ama gebi ahaanba way roonaadeen.
The response rate for the 12 people who had CAR T-cell daaweynta before was 75%, and 41.7% of those people had a complete response or better.
Dhammaan kooxda 79 bukaan, 92.4% ayaa sidoo kale diidmo u ah cudurrada haraaga ah ee ugu yar, ama tirada yar ee unugyada kansarka kuwaas oo mararka qaarkood sii jiri kara daaweynta ka dib oo keena in cudurku soo noqdo.
Astaanta badbaadada ee CT103A waxay ahayd mid wanaagsan oo fudud in wax laga qabto.
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 daawaynta. But most of the time, these reactions were mild or moderate and lasted about five days.
Saamaynta difaaca jirka ee unugyada neurotoxicity syndrome, jawaab celin difaac halis ah oo saameeya habdhiska dareenka, ayaa lagu arkay laba qof. Calaamaduhu waxay ahaayeen kuwo khafiif ah ama dhexdhexaad ah wayna baxeen.
Guud ahaan, CT103A ma aysan keenin jawaab celin difaac oo ka soo horjeeda daaweynta, inkastoo 16.5% bukaannada ay tijaabiyeen unugyada difaaca jirka ee CT103A.
Marxaladda 1-aad ee tijaabada FUMANBA-2 (NCT05181501), ilaa 20 bukaan oo dhowaan la helay, halis sare ayaa laga baarayaa bukaannada myeloma ee badan si loo eego haddii CT103A ay caawin karto.
