JW Therapeutics yalengeza chilolezo cha Investigational New Drug (IND) kuchokera ku National Medical Products Administration (NMPA) yaku China pophunzira za anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva® (relmacabtagene autoleucel jekeseni) pochiza ana ndi achikulire odwala omwe abwereranso kapena kukana B-cell acute lymphoblastic leukemia (r/r B-ALL).
B-cell acute lymphoblastic leukemia (B-ALL) ndi matenda omwe amapezeka kwambiri mwa ana [1]. Kukaniza mankhwala a chemotherapeutic omwe amachititsa kuti matenda ayambirenso kuyambiranso, komanso kupulumuka pambuyo poyambiranso kumakhala kovutirapo kwa odwala omwe ali ndi B-ALL. Chithandizo cha Salvage chemotherapy chikhoza kukhala chosankha, koma sikokwanira kuchiza matenda obwerera m'mbuyo kapena owopsa. Kupulumuka kwa nthawi yayitali kunali kochepa chifukwa chosayankhidwa bwino, chiwopsezo chochepa cha chikhululukiro, komanso chiwopsezo chachikulu cha kubwereranso pambuyo pa salvage chemotherapy. Pakali pano, palibe chithandizo choyenera cha r/r B-ALL. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) idawoneka ngati njira yodalirika, komabe, kupulumuka kwanthawi yayitali sikungakwaniritsebe kukhutiritsa[2]. Kubwereranso kwa matenda pambuyo pochizira kumakhalabe vuto lalikulu, ndipo njira zatsopano zothandizira odwala zimafunikirabe mwachangu kuti atalikitse moyo wautali kwa odwala omwe ali ndi r/r B-ALL.
Phunziroli (JWCAR029-006) gawo I, lotseguka, lotseguka, mkono umodzi, kafukufuku wokweza mlingo ku China, womwe cholinga chake ndi kuyesa chitetezo, mphamvu, ndi mbiri ya pharmacokinetics ya Carteyva® mwa ana ndi odwala achikulire omwe ali ndi r/r. B-ALL, komanso kudziwa mlingo wovomerezeka wa gawo II (RP2D).