mRNA vaccine for treating solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 clinical trial aims to evaluate the safety, tolerance, and preliminary efficacy of a neoantigen mRNA vaccine designed for patients with advanced solid tumors. The study involves selecting appropriate patients, performing biopsies for DNA/RNA sequencing, and producing a high-quality mRNA vaccine for local injection. Additionally, patients may receive cotreatment with PD1/PDL1/CTLA4 antibodies to enhance the vaccine's effectiveness. Clinical results will be closely monitored to assess the vaccine's anti-cancer function.

Why it matters

Who can join: the full rules

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.

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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 it's running

• Second Affiliated Hospital of Guangzhou Medical University
  Guangzhou, 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• VS-7375 for adults with KRAS G12D-mutated advanced solid tumors.

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• Using a modified cold virus to treat certain solid tumors

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.