Clinical trial · Interventional
Personalized Vaccine for Patients With Recurrent Malignant Glioma
Personalized Vaccine for Patients With Recurrent Malignant Glioma: a Single-arm, Single-center, Open-labeled Study
NCT04943718CI-TRIAL-00052477unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A single-arm, single-center, open-labeled study will be conducted with an aim to investigate the feasibility, safety, and efficacy of the personalized vaccine for patients with recurrent malignant glioma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Glioma | Glioma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| personalized vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- personalized vaccine
- description
- patients with recurrent malignant gliomas enrolled into this arm will receive the personalized vaccine through sub-cutaneous.
- interventionNames
- Biological: personalized vaccine
Primary outcomes (1)
- measure
- incidences of advent events and severe advent events
- timeFrame
- from initiation of study treatment to 28 weeks post-vaccination
- description
- would be monitored and measured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.X.)
Secondary outcomes (4)
- measure
- object response rate (ORR) according to iRANO criteria
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * age 18-70; * signed inform consent; * patients with recurrent malignant glioma; have received surgery, radiotherapy, chemotherapy; * patients' tumor tissue should have a high mutation load(\>10 TMB); be genetically unstable; at least have 10 neoantigens; * should be able to provide tumor tissue and peripheral blood for sequencing and flow cytometry analysis; * at least three months post last operation; one month after the completion of the last anti-drug therapy or radiotherapy; * have not received any immune therapy; * at least have one measurable lesion; * KPS \>60; * estimated survival \> 3 months * patients should have adequate organ and bone marrow function; Exclusion Criteria: * female patient is breastfeeding or pregnant; * known history of allergy to peptides or other stimulating factors (i.e. GM-CSF); * known history of Graft-Versus-Host Disease (GVHD); * participation in gene therapy; * other malignancy; * systemic disease: i.e., severe infection; HIV; * other conditions upon investigator's judgement;
References
Publications (0)
Data not yet available
No reference posted for this study.