Vaccination by homologous antigenic loading with DOC1021 as adjuvant therapy for glioblastoma: Phase I clinical trial results
Abstract
2014
Background:
Glioblastoma is a devastating tumor for which median overall survival (mOS) remains 14-18 months despite aggressive standard of care (SOC) treatment. Clinical studies of dendritic cell (DC) vaccination for GBM have shown promise but have been largely inconclusive. DC homologous antigenic loading leverages p38MAPK and mTORC1 signaling cascades to initiate cDC1-like skewing of monocyte-derived DC, leading to potent downstream induction of tissue-homing cytolytic memory effector T cells. Here we report results of a completed phase I study for glioblastoma (IDH-wt).
Methods:
This clinical trial evaluated autologous DC vaccine DOC1021 prepared from mobilized peripheral blood mononuclear cells (PBMC), loaded with autologous tumor lysate and amplified tumor mRNA, and administered bilaterally near deep cervical lymph nodes. Three courses of vaccine every 2 weeks plus weekly peg-IFN were administered after completion of chemoradiation. Four dose levels from 3.5 x 10
6
to 3.6 x 10
7
total vaccine cells were tested. Patients with subtotal resection or tumor progression prior to vaccination were not excluded.
Results:
Sixteen newly diagnosed patients completed treatment, median age 61 years (range 47-73), 94% MGMT unmethylated, 25% subtotal resected. OS at 12-months was 88% compared to expected ~60% for SOC and 5 patients are still alive at 19-30 months of follow-up. Two recurrent glioblastoma patients were also treated and survived for 10-12 months. Most common AEs…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 13 participants or records.
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