Vaccination using immune cells to treat solid tumors
Anti-cancer DC Cell Vaccination to Treat Advanced Solid Tumors: Phase I Clinical Trial
PHASE1 · Second Affiliated Hospital of Guangzhou Medical University · NCT06477614
This study is testing a new vaccine made from immune cells to see if it can help people with advanced solid tumors fight their cancer safely.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University (other) |
| Drugs / interventions | prednisone, immunotherapy |
| Locations | 1 site (Guanzhou, Guangdong) |
| Trial ID | NCT06477614 on ClinicalTrials.gov |
What this trial studies
This phase 1 clinical trial evaluates the safety and preliminary efficacy of a dendritic cell (DC) vaccine derived from heat shock protein gp96 to treat patients with advanced solid tumors. The process involves collecting DC cells from the patient's blood, co-culturing them with gp96, and then injecting the activated DC cells back into the patient. The study aims to assess the anti-cancer function of this immunotherapy approach while monitoring for safety and tolerance. Additionally, patients may receive adjuvants or immune checkpoint inhibitors to enhance the vaccine's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced solid cancers who have a life expectancy of more than 12 weeks and meet specific health criteria.
Not a fit: Patients with severe viral infections, known HIV positivity, or those who have undergone gene therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel immunotherapy option for patients with advanced solid tumors.
How similar studies have performed: While this approach is innovative, similar immunotherapy strategies have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. Patients with advanced cancer; 2. Life expectancy \>12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available high quality vaccine for human use; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. \- Exclusion Criteria: 1. Had accepted gene therapy before; 2. Severe virus infection such as HBV, HCV, HIV, et al; 3. Known HIV positivity; 4. Active infectious disease related to bacteria, virus,fungi,et al; 5. Other severe diseases that the investigators consider not appropriate; 6. Pregnant or lactating women; 7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day); 8. Other conditions that the investigators consider not appropriate.
Where this trial is running
Guanzhou, Guangdong
- The Second Affiliated Hospital of Guangzhou Medical University — Guanzhou, Guangdong, China (RECRUITING)
Study contacts
- Principal investigator: Zhenfeng Zhang, MD, PhD — Second Affiliated Hospital of Guangzhou Medical University
- Study coordinator: Zhenfeng Zhang, MD, PhD
- Email: zhangzhf@gzhmu.edu.cn
- Phone: 0086-020-39195965
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: Solid Tumor, Adult, DC, Solid Tumor, DC Vaccine, gp96