Kukadzi 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.
Mazita aya anowedzera kudomwa kwemushonga wenherera wegore rapfuura kubva kuboka rinotonga.
Aya mazita, ayo anopa rubatsiro rwemari nemutemo, anoitirwa kukurumidza kugadzirwa kwemishonga ine mukana wekurapa hosha dzakakomba, dzinotyisa, kana dzisina kujairika iyo parizvino isingakwane marapiro.
"Kushandisa ... yekugadzira pombi yechigadzirwa [uye] yakasanganiswa yekugadzira uye yekiriniki kugona, IASO ine chinangwa chekuunza shanduko, inorapika uye inokwanisika marapirwo anozadzisa izvo zvisingaite zvinodiwa pakurapa kuvarwere muChina pamwe nepasirese," kambani yakadaro muchiziviso chayo. .
Muyedzo weUS weCT103A unotarisirwa muna Chivabvu
Chimiro chekukurumidza chinokutendera kuti uende kuburikidza nekudzokorora uye kuona kana iwe uchikodzera kukurumidza kubvumidzwa uye kuongororwa kwekutanga. Rolling wongororo inoreva kuti kambani inogona kutumira muzvikamu zvechikumbiro chavanenge vakagadzirira, pachinzvimbo chekumirira kusvika zvikamu zvese zvaitwa sangano risati ratarisa chikumbiro.
Mvumo yekukurumidza, inodaidzwawo kuti "mvumo yezvimiro," inopiwa kune marapirwo anowanikwa nekukurumidza anozadza chinodiwa chekurapwa icho chisati chaitwa, chero humbowo hwekutanga hunoratidza kuti mabhenefiti ekurapwa anodarika njodzi.
Nezita reRMAT, unogona kutaura neFDA kutanga, kazhinji, uye padhuze. Panyaya yemvumo yekukurumidzira, humbowo hwekiriniki hunodiwa kusimbisa mabhenefiti ekurapa uye kuwana mvumo yakazara inogona kubva kune dzimwe nzvimbo kunze kwechinyakare chekusimbisa kiriniki kuyedza, iyo inowanzochengetedza nguva nemari.
Parizvino, CT103A yakangoyedzwa kuvarwere vemyeloma kuChina, uko yainzi inzira yekurapa uye yave kuongororwa nekukurumidza. Ikoko, IASO neInnovent Biologics vari kushanda pamwechete kugadzira CT103A.
Muna Zvita, FDA yakabvumidza chikumbiro cheIASO chemushonga mutsva wekuferefeta. Izvi zvaireva kuti CT103A inogona kushandiswa mukati kliniki miedzo muUnited States
A Phase 1b clinical trial (NCT05698303) ichaedza kurapwa kune vanhu vakuru gumi nevaviri vane RRMM kuti vaone kuti yakachengetedzeka uye inoshanda sei. Chidzidzo ichi chichaitwa kuMD Anderson Cancer Center paUniversity of Texas muHouston, Texas. Inotarisirwa kutanga muna Chivabvu.
Chimeric antigen receptor (CAR) T-cell therapy inoshanda nekuita kuti zvive nyore kune T-masero, ayo ari rudzi rwemasero ekudzivirira anogona kurwisa kenza, kuwana uye kurwisa kenza masero.
Kuunganidza T-masero emurwere uye nekuachinja murabhoritari kugadzira receptor, kana CAR, inoziva mapuroteni chaiwo pamasero egomarara ndiyo pfungwa huru kuseri kweiyi nzira. Kana aya masero einjiniya akadzoserwa mumuviri, anofanirwa kuwana nekuuraya maseru egomarara pasina kukuvadza masero ane hutano emuviri.
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-sero kurapwa that can make it hard to re-dose them if a person’s cancer comes back.
Mukutanga mutyairi Phase 1 kuyedzwa (ChiCTR1800018137) muChina, 18 vanhu vane RRMM vakapihwa kurapwa. Pashure perinenge gore, vose vakave nemhinduro kumushonga wacho. Vanosvika zvikamu zvitatu muzvina (72,2%) vaive nemhinduro yakakwana kana zvirinani, zvinoreva kuti bundu ravo rakanga raenda.
Kusvika parizvino, IOSA's CAR T-cell therapy yakaedzwa muChina chete
Mushure mezvo, muyedzo weChikamu 1/2 unonzi FUMANBA-1 (NCT05066646) wakatangwa kuChina kuyedza kuchengetedzwa uye kushanda kweCT103A muvakuru vanosvika zana nemakumi matatu nevaviri vane 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.
Kubva muna Ndira 21, 2022, CT103A yakanga yashandiswa kurapa vanhu makumi manomwe nepfumbamwe, uye nguva yeavhareji yekutevera yaive ingangoita mwedzi gumi.
Varwere ava vanga vatopfuura nepakati pemitsara mishanu yekurapa, mimwe yacho yaive immunomodulatory drugs, proteasome inhibitors, uye CD38 inhibitors. Gumi nevaviri (15.2%) vavo vakanga vatorapwa neBCMA-yakanangana neCAR-T cell therapy isiri yevanhu.
Mushure memazuva epakati pemazuva e16 ekurapwa, zvigumisiro zvakaratidza kuti varwere vakawanda (94.9%) vaiva nemhinduro shoma. Izvi zvaisanganisira 68.4% yevarwere vaiva nemhinduro yakakwana kana zviri nani uye 89.9% yevarwere vaiva nemhinduro yakanaka kwazvo kana zviri nani.
Vanhu gumi vane extramedullary myeloma, rudzi rwegomarara rinokura kunze kwemwongo, vose vakava nani kubva mukurapwa. Vanhu vese ava vakava nani mushure mekurapwa, uye 90% yavo yakava nani kana kuti zviri nani zvachose.
The response rate for the 12 people who had CAR T-cell kurapa before was 75%, and 41.7% of those people had a complete response or better.
Kubva muboka rose revarwere makumi manomwe nepfumbamwe, 79% vaivewo vasina kunaka kune chirwere chidiki chasara, kana huwandu hudiki hwemasero egomarara dzimwe nguva anogona kuramba mushure mekurapwa uye kuita kuti chirwere chidzoke.
Iyo yekuchengetedza mbiri yeCT103A yaive yakanaka uye iri nyore kubata.
Most patients (94.9%) had cytokine release syndrome, which is an immune response that can be dangerous and is often seen with CAR T-sero kurapwa. But most of the time, these reactions were mild or moderate and lasted about five days.
Immune effector cell-associated neurotoxicity syndrome, yakakomba immune system inokanganisa tsinga, yakaonekwa muvanhu vaviri. Zviratidzo zvavo zvaive zvakapfava kana pakati nepakati uye zvakaenda.
Kazhinji, CT103A haina kukonzera mhinduro dzekudzivirira dziviriro dzaive dzinopesana nekurapa, kunyangwe 16.5% yevarwere vakaongororwa kuti vane hutachiona hwekurwisa CT103A.
Muchiyedzo chePhase 1 FUMANBA-2 (NCT05181501), vanosvika makumi maviri vachangobva kuongororwa, vane njodzi yakawanda yevarwere vane myeloma vari kuongororwa kuti vaone kana CT20A ingavabatsira.
