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公開日:2021/11/13 / 最終更新日:2021/11/13
So, TRANSCEND-NHL-001 (TRANSCEND) was the pivotal part 1 seamless design trial in the United States of liso-cel in a complete of 269 patients aged 18 years and older with DLBCL, tFL, PMBCL, HGBCL, FL3B, and other remodeled indolent histologies who had relapsed or progressed after at the least two prior lines of therapy with an ECOG efficiency standing of 0-2.6 A complete of 344 patients underwent leukapheresis and 294 of these patients acquired liso-cel. Phase 1 enrolled seven patients and established the feasibility of manufacturing axi-cel and its protected administration to patients, utilizing the Car construct developed on the National Cancer Institute.18, 19 These seven patients were adopted by an additional two cohorts, totaling a hundred and one patients aged 18 years or older in the pivotal phase 2 portion of ZUMA-1.5 Patients with DLBCL, HGBCL, tFL, or PMBCL who had major refractory illness, disease refractory to second-line or subsequent therapy, or relapsed inside 1 year after autologous stem cell transplant (autoSCT) had been eligible for enrollment.
Patients with central nervous system (CNS) illness, Eastern Cooperative Oncology Group (ECOG) efficiency standing ≥2, prior allogeneic stem cell transplant (alloSCT), and prior anti-CD19-directed therapy have been excluded. Patients with prior alloSCT, active CNS illness, prior treatment with an anti-CD19 therapy, or an ECOG efficiency standing ≥ 2 were excluded.11 Leukapheresis was carried out on the treating middle no matter availability of a producing slot. Bridging anti-lymphoma therapy was allowed throughout product manufacturing. Within the JULIET trial, the ability to store cryopreserved apheresis products allowed leukapheresis any time after confirmation of eligibility, reasonably than after confirmation of an accessible manufacturing slot; thus, the interval from enrollment to tisa-cel infusion, relatively than the interval from leukapheresis to infusion, was reported. Per protocol, enrollment and leukapheresis occurred after affirmation of the availability of a producing slot. Patients with secondary CNS involvement by lymphoma had been eligible for enrollment as long as systemic lymphoma was also current, prior alloSCT was permitted in the absence of graft-versus-host illness or ongoing immunosuppression if not less than 90 days had handed from transplant to leukapheresis, and prior anti-CD19 remedy was allowed if CD19 was still detectable on tumor cells.
Data supporting the feasibility of manufacturing Car-T cells from cryopreserved patient samples have been previously reported.21, 22 The typical interval between enrollment and infusion of tisa-cel was 54 days and patients may receive bridging anti-lymphoma therapy for illness management throughout that time. PBMCs have been cryopreserved and saved regionally, then shipped to the manufacturing facility when a producing slot turned out there. Even the smallest details within the animation make the slot feel alive even if it’s an abandoned desert place exhibiting in the backdrop. Sometimes, สล็อต รวม ทุกค่าย though, it sounds a bit clunky as it tries to pair itself with the animation. The twin Thunderbolt ports actually double down on that nonetheless-underused connection, and the pair of USB 2.0 ports have turn out to be USB 3.0. Both are probably helpful for including external storage to augment the flash memory, however you might also need those extra connections to hook up dongles for Ethernet and FireWire.
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