Musi wa20 Chikunguru, Kushandiswa Kwemishonga Itsva(NDA) ye pCAR-19B yakagadzirwa yega nePrecision Biology yakagamuchirwa zviri pamutemo neChina National Medical Products Administration (NMPA). Chigadzirwa ichi ndicho chigadzirwa chekutanga cheCAR-T che leukemia yevana muChina, chinoshandiswa kurapa varwere vane makore 3-21 vane CD19-positive relapsed/refractory acute lymphoblastic leukemia (ALL).
Acute lymphoblastic leukemia (ALL) ndeimwe yemabundu anonyanya kuipa muvana uye ndiyo inonyanya kukonzera kufa kwevana nevechiri kuyaruka. Kurapa nemasero echimeric antigen receptor (CAR-T) kwakachinja kurapa kwemasero eB-cell ALL akadzokera shure/asingadzoreki (R/R), nemushonga wekutanga wakatenderwa neFDA, Kymriah(tisagenlecleucel) wakagadzirwa neNovartis, zvichivandudza zvakanyanya mwero wekuregererwa uye nguva yekurarama.
pCAR-19B chigadzirwa cheCAR-T cell chega chine CD19-specific single-chain variable fragment (scFv) yakagadzirwa kuti igadzirise matambudziko ekuchengetedza.
Muna Mbudzi 2023, pCAR-19B yakapihwa "Breakthrough Therapy Designation" neChina National Medical Products Administration yekurapa B-ALL.
Kushanda zvakanaka uye kuchengetedzeka kwepCAR-19B mukuyedzwa kwakakosha kwekiriniki kunosanganisira varwere vechiChinese vane R/R B-cell ALLyakaziviswa paMusangano weGore negore wechi66 weAmerican Society of Hematology (ASH).
Nzira Dzekushandisa: Muedzo uyu wechikamu chechipiri (NCT05334823) waive ongororo yechikamu chimwe chete, yakavhurika, ine nzvimbo dzakawanda. Varwere vane makore ≥ 3 uye ≤ makore 21 pavakaongororwa vaine CD19+ R/R B-ALL yakasimbiswa vakabatanidzwa. Mugumo mukuru waive wehuwandu hwekuregererwa (ORR), hunotsanangurwa sekuregererwa kwakazara (CR) pamwe neCR ine kupora kweropa kusina kukwana (CRi) mukati memwedzi mitatu mushure mekuisirwa.
Mhedzisiro: Kubva musi wa18 Kubvumbi, 2024, varwere 89 vakanga vanyoreswa uye vakaitwa leukapheresis, varwere 64 vachipihwa pCAR-19B infusion. Pakanga pasina nyaya dzekukundikana kwekugadzirwa. Pakati pevarwere vakapinzwa mushonga uyu, 6.25% (4/64) vakanga vasingashande zvakanaka uye 93.75% (60/64) vakanga vadzokera kumishonga yakawanda yekurapa kare kana kuisirwa allogeneic stem cell. Zera repakati raive makore 11 (kubva pa3 kusvika pa21), uye 56.25% (36/64) vaiva varume. Pamusoro pezvo, 75% (48/64) yevarwere vaiva nejini rimwe chete rine njodzi huru. Mutoro wepakati wemapfupa emubofu (BM) blast pakutanga waive 58.3% (kubva pa5% kusvika pa98%) nemutoro weBM blast wakakura (≥50%) wakaonekwa mu56.25% yevarwere.
Pakuongororwa kwemazuva mazana maviri negumi nerimwe (kubva pa35 kusvika pa750), ORR yakanakisa yaive 90.63% (58/64), ne78.13% yevarwere (50/64) vachiwana CR uye 12.5% yevarwere (8/64) vachiwana CRi, zvichipfuura kushanda kwezvigadzirwa zvekurapa zve anti-CD19 CAR-T zvakataurwa muR/R B-ALL. 98.27% (57/58) yevarwere vane ORR vakawana negative minimal residual disease (MRD)-negative relieval. ORR pamwedzi mitatu yaive 76.56% (49/64). Nguva yepakati yekupindura (DOR) yaive mwedzi gumi nembiri (95% confidence interval 7.66-20.96). Avhareji yekurarama kwese (OS) yaive mwedzi makumi maviri nematatu nembiri (95% confidence interval 9.86-NR).
Cytokine release syndrome (CRS) uye immune effector cell-associated neurotoxicity syndrome (ICANS) zvakaitika mu98.44% uye 50% yevarwere, zvichiteerana. Giredhi ≥3 CRS neICANS zvakaonekwa mu29.69% uye 39.06% yevarwere, zvichiteerana. Nguva yepakati yeGiredhi ≥3 CRS neICANS yaive mazuva mana nemazuva matatu, zvichiteerana. Hapana rufu rwakakonzerwa neCRS kana ICANS.
Mhedziso: Pasinei nemutoro wakakura wekuputika kweBM uye njodzi yakakura yekusiyana kwemajini, pCAR-19B yakaratidza mwero wekurerukirwa kwakanyanya, yakawana mwero wekurerukirwa kwakanyanya kweMRD-negative, mhinduro dzinogara kwenguva refu, uye nhoroondo yekuchengetedza inoshivirirwa. Chidzidzo ichi chinomiririra kuyedzwa kwekutanga kwakakosha kwekiriniki yeB-ALL yevana muvanhu vekuAsia, ichipa sarudzo itsva yekurapa kwevana vekuChina nevarwere vechidiki vane R/R B-ALL.
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.
Nhamba yefoni: 4008803716
Imeyili：myimmnet@163.com
Mareferensi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2. http://cq.news.cn/20240728/b0a74788930d4be7a45996be2808dd4f/c.html
4.https://ash.confex.com/ash/2024/webprogram/Paper206408.html
5. https://ashpublications.org/blood/article/140/Supplement%201/4625/491174/The-Safety-and-Efficacy-of-p-CAR-19B-a-Scfv
Nguva yekutumira: Mbudzi-22-2024