Su'esu'ega Fa'afoma'i Fou mo le Leukemia Lymphoblastic Leukemia ua Toe Fa'afo'i

Na faalauiloa e le JW Therapeutics le Investigational New Drug (IND) kilia mai le National Medical Products Administration (NMPA) o Saina mo le suʻesuʻeina o le anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva® (relmacabtagene autoleucel injection) i le togafitia o tamaiti ma talavou matutua mama'i ua toe fa'afo'i po'o refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

B-cell acute lymphoblastic leukemia (B-ALL) o le maʻi sili ona taatele i tamaiti [1]. Tete'e i vaila'au chemotherapeutic e mafua ai le toe fa'afo'i ma le alualu i luma o fa'ama'i, ma e le lelei le ola pe a mae'a le toe fo'i i tagata mama'i ma le B-ALL. O le fa'asaoina o le chemotherapy e mafai ona avea ma se filifiliga, ae e le lava e fa'amaloloina ai fa'ama'i toe fa'afo'i po'o fa'ama'i fa'aletonu. Na fa'atapula'aina le ola umi ona o le le lelei o le tali atu, maualalo le fa'amagaloga, ma le maualuga o le toe fa'afo'i pe a uma le chemotherapy. I le taimi nei, e leai se faʻataʻitaʻiga lelei togafitiga mo r / r B-ALL. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) na tulaʻi mai o se fuafuaga faʻamoemoe, e ui i lea, o le umi o le ola ola e le mafai ona ausia le faamalieina [2]. O le toe fo'i mai o fa'ama'i pe a mae'a togafitiga e tumau pea ose lu'itau tele, ma o lo'o mana'omia fa'avavevave togafitiga fou e fa'aumi ai le ola umi mo tagata mama'i e maua i le r/r B-ALL.

O lenei suʻesuʻega (JWCAR029-006) o se vaega I, tatala-igoa, tasi-lima, suʻesuʻega faʻateleina fua i Saina, lea e faʻamoemoe e iloilo le saogalemu, aoga, ma faʻamatalaga pharmacokinetics o Carteyva® i tamaiti ma talavou matutua maʻi ma r / r B-ALL, faʻapea foʻi ma le fuafuaina o le faʻasologa o le vaega II fautuaina (RP2D).