Clinical trial · Interventional
The Safety and Effectiveness of NV-A01 in Glioma Patients
Clinical Study on the Safety and Effectiveness of NV-A01 in the Treatment of Advanced Glioma Patients
NCT06193538CI-TRIAL-00072726unknownPhase 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)
The goal of this clinical trial is to learn about the safety and effectiveness of NV-A01 in the treatment of advanced glioma patients. The main questions it aims to answer are: 1. The safety of NV-A01 in the treatment of advanced glioblastoma patients. 2. The effectiveness of NV-A01 in treating patients with advanced glioblastoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Glioblastoma Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant NV-A01 adenovirus injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intratumoral injection of NV-A01 adenovirus
- interventionNames
- Drug: Recombinant NV-A01 adenovirus injection
Primary outcomes (1)
- measure
- Safety and Tolerabilityof NV-A01 in the treatment of advanced glioma patients as measured by Frequency of Grade 3 or Above Adverse Events
- timeFrame
- One months after the last injection
- description
- All events with a Grade 3 or above toxicity (defined by the NCI-CTCAE 5.0) will be tabulated by event and by relationship to NV-A01.
Secondary outcomes (2)
- measure
- Evaluate the effectiveness of NV-A01 in treating patients with advanced glioblastoma
- timeFrame
- Six months after the last injection
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with advanced malignant glioma confirmed by histopathology; 2. Patients who have received radiotherapy and/or temozolomide (TMZ) treatment and have residual or recurrent tumors; 3. Patients diagnosed with lesions ≥ 1.0 cm after qualified assessment; 4. KPS score ≥ 60 points; 5. The subjects had informed consent to this study before the experiment and voluntarily signed an informed consent form. Exclusion Criteria: 1. Patients with unstable central nervous system metastases or meningeal metastases with clinical symptoms, with a risk of brain herniation or severe brain herniation, and judged by researchers as unsuitable for inclusion; 2. Patients with severe cardiovascular diseases, active autoimmune diseases, and other diseases that have been determined by researchers to be unsuitable for enrollment; 3. Patients who have received immunotherapy in the past and have an irAE level ≥ 3, and have been determined by the researchers to be unsuitable for enrollment; 4. Patients with an expected survival period of less than 3 months and judged by the researchers as unsuitable for enrollment; 5. Researchers believe that patients with other serious systemic diseases or other reasons are not suitable for participating in this clinical study.
References
Publications (0)
Data not yet available
No reference posted for this study.