OncoMatch/Clinical Trials/NCT07306299
A Phase I Clinical Trial of a mRNA Vaccine for Recurrent or Progressive High-grade Glioma
Is NCT07306299 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Glioma-related multi-target mRNA vaccines for glioma, high grade.
Treatment: Glioma-related multi-target mRNA vaccines — This clinical trial is designed to evaluate the safety and efficacy of a universal mRNA vaccine targeting a panel of glioma-associated mutations in patients with recurrent or progressive high-grade glioma. The primary objectives are to address the following key questions: 1) Is the mRNA vaccine safe for this patient population? 2) Does the vaccine stimulate an anti-tumor immune response and promote tumor regression? Participants will receive the vaccine according to the following schedule: 1. one injection per week for four consecutive weeks, followed by one injection every four weeks for four cycles, and subsequently, one injection every 12 weeks for maintenance. 2. Safety and efficacy assessments, including detailed recording of adverse events and tumor growth evaluation, will be conducted at follow-up visits scheduled for weeks 6, 12, and months 6, 9, 12, 18, 24, and 36 post-treatment initiation.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: BRAF v600e
Required: EGFR viii
Required: H3F3A (H3 K27M) g34r
Required: H3F3A (H3 K27M) k27m
Required: HIST1H3B k27m
Required: IDH1 r132h
Required: PIK3CA h1047r
Disease stage
Required: Stage WHO GRADE III, WHO GRADE IV (WHO CNS)
Grade: 34 (WHO CNS)
CNS WHO Grade 3-4 glioma confirmed by post-surgical histopathology
Prior therapy
Must have received: radiation therapy — standard therapy
progression per RANO criteria on MRI following standard therapy (radiotherapy plus temozolomide chemotherapy)
Must have received: cytotoxic chemotherapy (temozolomide) — standard therapy
progression per RANO criteria on MRI following standard therapy (radiotherapy plus temozolomide chemotherapy)
Lab requirements
Blood counts
ANC ≥1.5 × 10⁹/L; Platelet count ≥100 × 10⁹/L; Hemoglobin ≥90 g/L (without transfusion or hematopoietic growth factor support within 14 days)
Kidney function
Serum creatinine ≤1.5 × ULN OR estimated creatinine clearance ≥50 mL/min (Cockcroft-Gault)
Liver function
ALT ≤2.5 × ULN; AST ≤2.5 × ULN; TBIL ≤1.5 × ULN
Cardiac function
LVEF ≥50% without clinically significant pericardial effusion on echocardiogram; no clinically significant ECG abnormalities
Absence of significant bone marrow, cardiac, pulmonary, or renal dysfunction, defined as: Hematologic (without transfusion or hematopoietic growth factor support within 14 days): ANC ≥1.5 × 10⁹/L; Platelet count ≥100 × 10⁹/L; Hemoglobin ≥90 g/L. Hepatic Function: ALT ≤2.5 × ULN; AST ≤2.5 × ULN; TBIL ≤1.5 × ULN. Renal Function: Serum creatinine ≤1.5 × ULN OR estimated creatinine clearance ≥50 mL/min (Cockcroft-Gault). Coagulation: APTT ≤1.5 × ULN; INR ≤1.5 × ULN. Other: LVEF ≥50% without clinically significant pericardial effusion on echocardiogram; no clinically significant ECG abnormalities; Baseline oxygen saturation >92% on room air.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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