Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06195384

Anti-cancer Neoantigen mRNA Vaccine to Treat Solid Tumors

Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-26

30

Participants Needed

1

Research Sites

712 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Anti-cancer Neoantigen mRNA Vaccine to Treat Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with advanced cancer
  • Life expectancy greater than 12 weeks
  • Adequate heart, lung, liver, kidney, and blood function
  • Availability of high quality vaccine for human use
  • Informed consent explained to, understood by, and signed by patient or guardian; patient or guardian given a copy of the consent
Not Eligible

You will not qualify if you...

  • Prior acceptance of gene therapy
  • Severe viral infections such as hepatitis B, hepatitis C, or HIV
  • Known HIV positivity
  • Active infectious diseases related to bacteria, virus, or fungi
  • Other severe diseases deemed inappropriate by investigators
  • Pregnant or lactating women
  • Receiving systemic steroid treatment at or above 0.5 mg prednisone equivalent per kg per day
  • Other conditions deemed inappropriate by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Actively Recruiting

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Research Team

Z

Zhenfeng Zhang, MD, PhD

CONTACT

B

Bingjia He, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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