Musi wa1 Kurume, 2024, China National Medical Products Administration (NMPA) yakabvumidza kuburitswa kweCAR-T cell product Zevorcabtagene AutoLeucel (Zevor-cel, CT053) yekurapa varwere vakuru vane reback or refractory multiple myeloma vakarapwa mushure mekurapwa kanenge katatu (vachishandisa kanenge imwe proteasome inhibitor uye immune modulator).
Rondedzero iyi inonyanya kubva pakuyedzwa kwekiriniki kwechikamu chechipiri chechikamu chakavhurika, chine ruoko rumwe chete, uye chine nzvimbo dzakawanda (LUMMICAR STUDY 1,NCT03975907) muChina, iyo yakawana chiyero chekuregerera 100%.
Varwere gumi nevana vane makore makumi mashanu nemana (34-62), vakapihwa mushonga we zevor-cel kamwe chete. Kubva musi wa17 Chikunguru, 2023, nguva yekutevera yaive mwedzi 37.7 (mwedzi 14.8-44.2). Muyero wemhinduro yose (ORR) waive 100% (14/14) nevarwere 78.6% (11/14) vachiwana mhinduro yakakwana (CR) kana mhinduro yakakwana (sCR); negativity shoma yechirwere (MRD) yakawanikwa muvarwere vese vachiwana CR kana sCR. Nguva yemhinduro yepakati (mDOR) yaive mwedzi 24.1 muvarwere vese uye mwedzi 26.0 kune avo vachiwana CR kana sCR. Kurarama kwepakati pasina progression-free (mPFS) kwaive mwedzi 25.0. Huwandu hwevarwere vanomwe (50%) vakaregererwa kwenguva inopfuura mwedzi 24. Avhareji yekurarama kwese (OS) haina kusvika, uye 92.9% (13/14) yevarwere vaive vachiri vapenyu pamwedzi wechi36.
Kuchengetedzeka
Zvose, kuchengetedzeka kwe zevor-cel kwaikwanisika. Pakanga pasina zviitiko zve ≥ Grade 3 cytokine release syndrome (CRS). Pakanga pasina zviitiko zve immune effector cell-associated neurotoxicity syndrome (ICANS) zvegiredhi ripi neripi. Zvirwere zvitatu zvine chekuita nekurapwa zvakaonekwa. Varwere vatatu vakasangana nezviitiko zvakakomba (SAE) kusanganisira varwere vaviri vaiva neSAEs dzine chekuita nekurapwa dzaive pulmonary infection uye tumor lysis syndrome. Pakanga paine vanhu vaviri vakafa pachidzidzo ichi; hapana kana mumwe wavo akanga ane chekuita ne zevor-cel.
Mhedziso
zevor-cel yakaratidza kuchengetedzeka kunokurudzira nemhinduro dzakadzika uye dzinogara kwenguva refu dzinoenderana nemigumisiro yekutanga.
Parizvino, kune mimwe miedzo yakawanda yeCAR-T muChina, uye vari kutsvaga varwere. Kuti muwane mazano pamusoro pemishonga mitsva netekinoroji, munogona kubata Beijing South Region Oncology Hospital International Department: 4008803716.
Mareferensi
2.http://sh.news.cn/20240314/2913c85a84be4fbf9345efbd48006971/c.html
3.http://myimm.net/mianyizhiliao/1413.html
4.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20240301143753188.html
Nguva yekutumira: Gumiguru-31-2024