Evaluating NV-A01 for treating advanced glioblastoma
Clinical Study on the Safety and Effectiveness of NV-A01 in the Treatment of Advanced Glioma Patients
PHASE1 · First Affiliated Hospital of Wannan Medical College · NCT06193538
This study is testing a new injection called NV-A01 to see if it can safely help people with advanced glioblastoma who have already had other treatments.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Wannan Medical College (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Wuhu, Jiangsu) |
| Trial ID | NCT06193538 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and effectiveness of NV-A01, a recombinant adenovirus injection, in patients with advanced glioblastoma. The study will focus on patients who have previously undergone radiotherapy and/or temozolomide treatment and have residual or recurrent tumors. By monitoring the participants' responses, the trial seeks to determine both the safety profile and the therapeutic efficacy of NV-A01 in this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with advanced malignant glioma who have received prior treatments and have measurable residual or recurrent tumors.
Not a fit: Patients with unstable central nervous system metastases or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced glioblastoma, potentially improving survival and quality of life.
How similar studies have performed: While this approach is novel, similar studies targeting advanced glioblastoma have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhu, Jiangsu
- Wannan medical college hospital — Wuhu, Jiangsu, China (RECRUITING)
Study contacts
- Principal investigator: Xiao Chun Jiang, Doctor — Wannan Medical College Hospital
- Study coordinator: Jie Shen, Doctor
- Email: 5845348@qq.com
- Phone: 86 553 5738200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Glioblastoma Patients