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Anti-cancer Neoantigen Polypeptide Vaccine to Treat Solid Tumors

RECRUITINGPhase 1Sponsored by Second Affiliated Hospital of Guangzhou Medical University
Actively Recruiting
PhasePhase 1
SponsorSecond Affiliated Hospital of Guangzhou Medical University
Started2024-06-04
Est. completion2029-12-30
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

Summary

The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate polypeptide 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 polypeptide vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the polypeptide vaccine immunotherapy on human cancers will firstly be evaluated.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
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.

Conditions2

CancerSolid Tumor, Adult

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