DOC1021 (dubodencel) DC vaccine expands memory T cells with low tox in GBM chemoradiation combo

DOC1021 is an autologous dendritic-cell immunotherapy made by tandem loading patient DCs with autologous tumor mRNA plus tumor lysate to drive broad antigen presentation and a cDC1-like, CD8+ effector program; in a pooled Phase I (Study 8148; NCT04552886) + expanded-access cohort, it was given after resection and standard chemoradiation in newly diagnosed/recurrent IDH-wt GBM (N=25; 88% MGMT unmethylated; 24% subtotal resection; 16% recurrent). Safety was largely flu-like symptoms/injection-site reactions with no DLTs; one grade 3 cerebral edema resolved and dosing continued, and pseudo-progression within ~6 months post-vaccination was “common.” Efficacy was not reported as mOS/mPFS/ORR, but at data cut 7/21 newly diagnosed patients were alive ~9–30 months post-surgery and 2/4 recurrent patients were alive ~16–20 months post–second resection; immunologically, post-vaccine PBMC showed CD4+ TCM expansion in 17/20 (mean +28.6%, p=0.0006), CD8+ TCM expansion in 15/20 (mean +26.8%, p=0.001), and higher CD127 on CD8+ T cells in 18/20 (mean MFI +72.2%, p=0.03). In context, contemporary SOC for newly diagnosed GBM remains maximal resection + RT/TMZ with historical mOS ~14.6 months in the Stupp regimen (and real-world MGMT-unmethylated outcomes often ~12 months), while recurrent GBM systemic options typically yield mOS around ~10 months in randomized datasets—so the survival “alive at timepoint” signals here are hard to benchmark without Kaplan–Meier endpoints and matched controls.