This is a single-center, open-label, dose-escalation, multiple-dose investigator-initiated trial (IIT). The trial aims to evaluate the safety and tolerability of autologous dendritic cell injection sensitized with tumor neoantigens (YS247) in participants with recurrent or progressive glioblastoma, as well as to assess preliminary efficacy and pharmacodynamic characteristics. The study consists of four phases: screening, baseline, treatment, and follow-up. During the treatment phase, participants will be assigned to three dose groups (low, medium, and high) and enrolled following the "3+3" dose-escalation principle. YS247 will be administered subcutaneously once every 2 weeks for a total of 8 consecutive doses.
Age 18-75 years (inclusive), any gender.
Histologically confirmed GBM (WHO Grade IV).
Recurrence/progression confirmed by MRI after standard therapy (surgery, Stupp protocol); ≥1 measurable lesion (max diameter ≥1.0 cm) on contrast-enhanced MRI per RANO criteria.
KPS score ≥60, expected survival ≥6 months.
Any other active malignancy.
Participation in another clinical trial within 4 weeks before enrollment.
Prior gene transfer therapy.
Concurrent anti-tumor therapy within 4 weeks before initial treatment (except allowed bridging); blood transfusion, EPO, G-CSF, or GM-CSF within 14 days before PBMC apheresis.
Single group
Neoantigen DC Vaccine (YS247) for Glioblastoma
Biological/VaccineExploratory Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) in Patients with Recurrent or Progressive Glioblastoma
Safety and Treatment Tolerability
Evaluate the incidence of treatment-related adverse events (TRAEs) of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247, Beijing YSCell Biotech Co., Ltd., abbreviated as YS) in patients with recurrent or progressive glioblastoma based on CTCAE v5.0, to assess the safety and tolerability of the product.
Maximum Tolerated Dose (MTD) and Recommended Expanded Dose(RP2D)
Based on the incidence of dose-limiting toxicities (DLTs), establish the MTD of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) for patients with recurrent or progressive glioblastoma, and define the RP2D. DLT is defined as any study drug-related AE (per CTCAE 5.0) or laboratory abnormality occurring from first dose to 4 weeks post-dose, unrelated to disease progression, comorbidity, or concomitant medication, including: 1. CTCAE Grade 3 non-hematological toxicity lasting \>7 days. 2. Immune-related Grade 3 pneumonia, recurrent Grade 2 pneumonia. 3. Other Grade 3 irAE not recovering to ≤Grade 2 in 3 days or ≤Grade 1 in 14 days with intervention. 4. CTCAE Grade 4 non-hematological toxicity. 5. CTCAE Grade 4 hematological toxicity lasting \>7 days. 6. CTCAE Grade 5 toxicity of any type. 7. Any unexpected toxicity requiring treatment termination per investigator/sponsor judgment.
Disease Control Rate (DCR)
Determined per RANO criteria via radiographic evaluation of intracranial tumor lesions.
Duration of Response (DoR)
Calculated per RANO criteria based on serial radiographic tumor lesion assessments.
the safe and efficacious dose range
Characterized based on the incidence of dose-limiting toxicities (DLTs) and anti-tumor response data assessed per RANO criteria
Objective Response Rate (ORR)
Determined per Response Assessment in Neuro-Oncology (RANO criteria) via radiographic evaluation of intracranial tumor lesions.
Neoantigen-specific T cell count
Peripheral blood mononuclear cells (PBMCs) collected at scheduled visits to quantify neoantigen-specific T cell counts by IFN-γ ELISpot assay.
T cell activation phenotypes
Peripheral blood mononuclear cells (PBMCs) collected at scheduled visits to detect activation phenotypes of neoantigen-specific T cells via multi-color flow cytometry.
Cytokine secretion level of neoantigen-specific T cells
Peripheral blood plasma collected at scheduled visits to measure cytokine secretion of neoantigen-specific T cells using ELISA assay.
T cell receptor clonotype diversity and clonal expansion
Peripheral blood mononuclear cells (PBMCs) collected at scheduled visits to analyze neoantigen-specific T cell receptor clonotype diversity and clonal expansion by full-length TCR sequencing.
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