Clinical trial NCT06193538: The Safety and Effectiveness of NV-A01 in Glioma Patients
Official title: Clinical Study on the Safety and Effectiveness of NV-A01 in the Treatment of Advanced Glioma Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Glioblastoma Patients
Lead sponsor: First Affiliated Hospital of Wannan Medical College
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
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
Secondary outcomes:
measure: Evaluate the effectiveness of NV-A01 in treating patients with advanced glioblastoma
timeFrame: Six months after the last injection
measure: Developing pharmacodynamic indicators Discovering pharmacodynamic indicators Discovering pharmacodynamic indicators
timeFrame: Six months after the last injection
Other outcomes:
Locations:
city: Wuhu
country: China
facility: Wannan medical college hospital
state: Jiangsu
Study officials:
affiliation: Wannan Medical College Hospital
name: Xiao Chun Jiang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: