Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intratumoral injection of NV-A01 adenovirus | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant NV-A01 adenovirus injection | Drug | Patients with advanced glioblastoma were intratumoral injected with NV-A01. Or the NV-A01 was injected after tumor resection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerabilityof NV-A01 in the treatment of advanced glioma patients as measured by Frequency of Grade 3 or Above Adverse Events | 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. | One months after the last injection |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of NV-A01 in treating patients with advanced glioblastoma | 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). | Six months after the last injection |
| Developing pharmacodynamic indicators Discovering pharmacodynamic indicators Discovering pharmacodynamic indicators |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Shen, Doctor | Contact | 86 553 5738200 | 5845348@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao Chun Jiang, Doctor | Wannan Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wannan medical college hospital | Recruiting | Wuhu | Jiangsu | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
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. |
| Six months after the last injection |