I-Omidubicel igunyazwe yi-USFDA ukunciphisa isikhathi sokululama kwe-neutrophil kanye nokutheleleka ezigulini ezine-hematological malignancies.

Kwangathi i-2023: I-Omidubicel-onlv (i-Omisirge, i-Gamida Cell Ltd.) igunyazwe i-Food and Drug Administration ukuze isetshenziswe ezigulini zabantu abadala kanye nezingane (ezineminyaka engu-12 ubudala nangaphezulu) ezinezifo ze-hematological ezihlelelwe ukuthola ukufakelwa igazi ngenkaba ngemva kwe-myeloablative conditioning. ukuze kusheshiswe ukululama kwe-neutrophil nokunciphisa ingozi yokutheleleka.

Ku-Study P0501 (NCT02730299), ilebula evulekile, i-multicenter, isivivinyo esingahleliwe sokufakelwa kwe-omidubicel-onlv noma ukufakelwa kweyunithi yegazi lentambo engalawulwa (UCB) ngemva kwesimo se-myeloablative ezigulini ezine-hematological malignancies, ukuphumelela nokuphepha kokwelashwa kwahlolwa. Isamba sabantu abayi-125 banikezwa ngokungahleliwe, kwathi abangama-62 bathola i-omidubicel-onlv kwathi abangama-63 bathola i-UCB. Iziguli ezingu-52 zine-omidubicel-onlv transplantation, enomthamo omaphakathi we-9.0 X 106 cells/kg (ububanzi obungu-2.1 - 47.6 X 106 cells/kg) wamaseli e-CD34+. Engalweni ye-UCB, iziguli ezingama-56 zineyunithi yentambo eyodwa noma ezimbili (ama-66% athole amayunithi ezintambo ezimbili) afakwe. Umthamo wamaseli we-CD34+ omaphakathi ezigulini ezingama-42 ezazinemithamo yeseli encibilikisiwe erekhodiwe yayingu-0.2 X 106 amaseli/kg (ububanzi obungu-0.0 - 0.8 X 106 amaseli/kg). Kwakunezinye izinqubo zokulungisa ezisetshenzisiwe, njengalezo ezisekelwe ku-chemotherapy noma i-Total Body Irradiation.

Isikhathi sokululama kwe-neutrophil ngemva kokufakelwa kanye nemvamisa ye-Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Ibanga lesi-2/3 lezifo zesikhunta zeBanga lesi-3 ngoSuku lwe-100 ngemva kokufakelwa kwakuyizinyathelo eziyinhloko zomphumela wokuphumelela. Isikhathi esimaphakathi sokutholwa kwe-neutrophil kwakuyizinsuku eziyi-12 (95% CI: izinsuku eziyi-10-15) kulabo abathola i-omidubicel-onlv, kanye nezinsuku ezingama-22 (95% CI: izinsuku eziyi-19-25) kulabo abathola i-UCB. Engalweni ye-omidubicel-onlv, ama-87% eziguli kanye nama-83% alabo abathola i-UCB bathola ukululama kwe-neutrophil. NgoSuku lwe-100 ngemva kokufakelwa kabusha, izehlakalo ze-BMT CTN yeBanga lesi-2/3 lokutheleleka kwefungal noma isikhunta seBanga lesi-3 kwakungama-39% kanye nama-60%, ngokulandelana, emaqenjini amabili.

Izinto ezinqumayo zihlanganisa Isexwayiso Esinebhokisi sokusabela okufayo noma okusongela ukuphila, i-graft versus host disease (GvHD), i-engraftment syndrome, nokwehluleka kokuxhunyelelwa, okufana nalokho kwemithi ye-UCB egunyaziwe. I-Omidubicel-onlv yanikezwa abantu abangu-117 kunoma yisiphi isifo; kubo, ama-47% aba ne-infusions, ama-58% aba ne-Acute GVHD, ama-35% athola i-GVHD engapheli, kanti u-3% waba nokwehluleka kokuxhunyelelwa.

Izimpendulo ezimbi kakhulu zeBanga le-3-5 ezigulini ze-Study P0501 ezine-hematological malignancies zazibuhlungu (33%), ukuvuvukala kwe-mucosal (31%), umfutho wegazi ophezulu (25%), kanye nobuthi besisu (19%).

Umthamo onconyiwe we-omidubicel-onlv ukufakwa okubili okulandelanayo okuhlanganisa okulandelayo:

• i-Cultured Fraction: ubuncane obungu-8.0 × 10⁸ amaseli asebenzayo anenani elincane elingamaphesenti angu-8.7 amaseli e-CD34+ kanye nobuncane obungu-9.2 × 10⁷ amaseli e-CD34+ esewonke, alandelwe ngu
• Ingxenye Engasikiwe: ubuncane obungu-4.0 × 10⁸ inani lamaseli asebenzayo anobuncane be-2.4 × 10⁷ Amaseli e-CD3+.

Imininingwane egcwele ye-Omisirge izotholakala lapha.