RecruitingPhase 1NCT06195384

Anti-cancer Neoantigen mRNA Vaccine to Treat Solid Tumors

Anti-cancer Neoantigen mRNA Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

30 participants

Start Date

May 8, 2024

Study Type

INTERVENTIONAL

Conditions

Solid Tumor, Adult

Summary

The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate mRNA sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the mRNA vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the mRNA vaccine immunotherapy on human cancers will firstly be evaluated.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria2

\. 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 Criteria8

Had accepted gene therapy before;
Severe virus infection such as HBV, HCV, HIV, et al;
Known HIV positivity;
Active infectious disease related to bacteria, virus,fungi,et al;
Other severe diseases that the investigators consider not appropriate;
Pregnant or lactating women;
Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
Other conditions that the investigators consider not appropriate.