Uvavanyo olutsha lweklinikhi lokubuyela kwakhona kwi-Acute Lymphoblastic Leukemia

I-JW Therapeutics ibhengeze imvume yoPhando oluTsha lweChiza (IND) kwi-National Medical Products Administration (NMPA) yaseTshayina kuphononongo lwe-anti-CD19 autologous chimeric antigen receptor T (CAR-T) imveliso ye-cell immunotherapy Carteyva® (relmacabtagene autoleucel injection) ekunyangeni abantwana kunye nezigulana zabantu abadala abaphinda-phinda okanye abachasayo B-cell acute lymphoblastic leukemia (r/r B-ALL).

I-B-cell acute lymphoblastic leukemia (B-ALL) yeyona nto ixhaphakileyo kunyango lwabantwana[1]. Ukuchasana nee-agent ze-chemotherapeutic ezikhokelela ekubuyeleni kwesifo kunye nokuqhubela phambili, kunye nokusinda emva kokubuyela kwimeko embi kwizigulane ezine-B-ALL. I-chemotherapy ye-Salvage inokuba yinto ekhethiweyo, kodwa akwanelanga ukunyanga isifo esiqatha okanye esibuhlungu. Ukusinda kwexesha elide kwakulinganiselwe ngenxa yokungaphenduli kakuhle, izinga lokuxolelwa okuphantsi, kunye nezinga eliphezulu lokuphinda ubuyele emva kwe-chemotherapy yokuhlangula. Okwangoku, akukho nyango lusemgangathweni olusebenzayo lwe-r/r B-ALL. I-allogeneic hematopoietic stem cell transplantation (i-allo-HSCT) yavela njengesicwangciso esithembisayo, nangona kunjalo, izinga lokusinda kwexesha elide alikwazi ukufumana ulwaneliseko[2]. Ukubuyela kwakhona kwesifo emva konyango luhlala luyingxaki enkulu, kwaye ukhetho lwenoveli yonyango lusafuneka ngokukhawuleza ukwandisa ukusinda kwexesha elide kwizigulane ezine-r / r B-ALL.

Olu phononongo (JWCAR029-006) isigaba I, ileyibhile evulekileyo, ingalo-nye, isifundo sokunyuka kwethamo e-China, esijolise ekuvavanyeni ukhuseleko, ukusebenza kakuhle, kunye neprofayili ye-pharmacokinetics yeCarteyva® kwizigulane zabantwana kunye nabaselula abadala abane-r / r. B-ALL, kunye nokumisela i-dose yesigaba II esicetyiswayo (RP2D).