Ngomhla wesi-7 kweyeThupha, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) libhengeze ukuba inaliti ye-PA3-17 icetyisiwe ukuba ifakwe kunyango oluphambili, olujoliswe kunyango lwezigulane zabantu abadala abane-T-cell ephinde yabuyela kwi-relaxative/refractory acute lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL).
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-ID ye-WeChat: 17801183037
I-imeyile：myimmnet@163.com
Izigulane ezine-T-lymphoblastic leukemia/lymphoma ephinde yabuya/engasabonakaliyo (r/r T-ALL/LBL) zibonakaliswa ngokwezonyango ngokuqhubeka kwesifo ngokukhawuleza, ukubikezela okubi kunye nokungabikho kweendlela zonyango. Okwangoku, yiNailabine kuphela eyavunywa yi-FDA ngo-2005 kunyango lwezigulane ze-T-ALL/LBL ezingazange ziphendule ubuncinane kwiindlela ezimbini ze-chemotherapy okanye eziphinde zabuya emva konyango, nge-ORR engama-31% kunye ne-CR engama-23%. Ke ngoko, kukho imfuneko engxamisekileyo yokuphuhlisa ezinye iindlela ezisebenzayo. Ngaphandle kokubonakaliswa kwayo kwiiseli ze-T eziqhelekileyo kunye ne-NK kwaye akukho kubonakaliswa kwezinye iiseli zezicubu, i-CD7 ibonakaliswa kakhulu kwiiseli ze-T-ALL/LBL. Ke ngoko, i-CD7 ithathwa njengeyona nto iphambili ekuphuhlisweni konyango lwe-CAR-T kwi-T-ALL/LBL. Nangona kunjalo, umngeni kukuphepha i-fratricide ebangelwa kukubonakaliswa kwe-CD7 kwiiseli ze-T. Abaphandi baphuhlise inaliti yeseli ye-CAR-T esekelwe kwi-CD7 nano antibodies, ebizwa ngokuba yi-PA3-17 injection, ngokuthintela ukubonakaliswa kwemolekyuli ye-CD7 kumphezulu weeseli ze-T ngokusebenzisa i-anti-CD7 protein expression blocker (PEBL).
Idatha yokulandelela ixesha elide evela kuvavanyo lweklinikhi lweSigaba soku-1 lwe-PA3-17 injection yonyango lwe-relapse/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) iboniswe kwingqungquthela yezemfundo enegunya lehlabathi i-EHA 2025.
Ukususela nge-19 kaFebruwari 2025, izigulane ezili-13 zizonke zabhaliswa (izigulane ezi-3 kwidosi yoku-1, ezi-2, ezi-3, nezi-4 kwiqela le-RP2D), zonke zafumana inaliti enye ye-PA3-17 zaza zagqiba uvavanyo lweentsuku ezingama-28 lokunciphisa ubuthi (DLTs). I-RP2D yasekwa kwi-2×10⁶ CAR-T/kg ngokusekelwe kwi-pharmacokinetics, ukhuseleko kunye nokusebenza ngaphaya kwale dosi. Akukho DLTs zenzekileyo kwaye idosi ephezulu enyanyezelweyo (MTD) ayizange ifikelelwe. Ukwenzeka kwe-Cytokine release syndrome (CRS) yayiyi-84.6% (G3:23.1%, akukho G4), ngelixa i-immune effector cell-associated neurotoxicity syndrome (ICANS) yayilinganiselwe kwi-G1-2 (15.4%). Idatha yokusebenza kakuhle ibonise ukuba izinga lokuphendula elichanekileyo (ORR) yayiyi-84.6% (11/13) kwaye i-76.9% (10/13) ifumene ukukhululwa okupheleleyo/ukukhululwa okupheleleyo kunye nokubuyiselwa kokubala okungaphelelanga (CR/CRi). Okumangalisayo kukuba, i-69.2% (9/13, izigulane ezisi-8 ze-CR) zigcine impendulo kwiinyanga ezi-3, kunye ne-50.0% (4/8) egcina i-CR＞iinyanga ezili-15 emva kokufakwa ngaphandle kokufakelwa kwe-stem cell emva koko (SCT), kwaye ezimbini zazo zaziseneeseli ze-CAR-T ezinokubonwa kwiinyanga ezingama-21. Okuphawulekayo kukuba, isigulane esasinyangwe kakhulu [ngaphambi kokufakelwa kwe-Hematopoietic Stem Cell (HSCT), isifo esikhulu ＞7cm] sifumene i-CR ngosuku lwama-28 kunye ne-HSCT yesibini kwiinyanga ezi-6.
Inaliti ye-PA3-17 ibonakalise ukunyamezeleka okuhle, umsebenzi onzulu noqhubekayo kwizigulane ezinyangwe kakhulu ze-r/r T-ALL/LBL, apho ama-50% ezigulane ze-CR zisala ziphila okanye/kwaye zingenalo ukuqhubela phambili kunyaka omnye.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Ixesha lokuthumela: Agasti-13-2025