Advanced Glioblastoma Patients
Conditions
Brief summary
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.
Interventions
DRUGRecombinant NV-A01 adenovirus injection
Patients with advanced glioblastoma were intratumoral injected with NV-A01. Or the NV-A01 was injected after tumor resection.
Sponsors
First Affiliated Hospital of Wannan Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This trial is a single arm, single center IIT clinical study to evaluate the safety and efficacy of NV-A01 in patients with advanced glioblastoma.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerabilityof NV-A01 in the treatment of advanced glioma patients as measured by Frequency of Grade 3 or Above Adverse Events | One months after the last injection | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of NV-A01 in treating patients with advanced glioblastoma | Six months after the last injection | Evaluate objective response rate (ORR), disease control rate (DCR), and progression free survival (PFS) according to the evaluation criteria for solid tumor efficacy (RECIST 1.1). |
| Developing pharmacodynamic indicators Discovering pharmacodynamic indicators Discovering pharmacodynamic indicators | Six months after the last injection | Proportion of CD3+, CD4+, CD8+T cells and the expression of CD69 on the surface of T cells in peripheral blood are detected by flow cytometry. The concentration of IL2 and IFN-gamma in plasma are measured by ELISA. Samples are collected prior to the administration of NV-A01 and at regular intervals after treatment. |
Countries
China
Contacts
Primary ContactJie Shen, Doctor
Outcome results
None listed