CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 30 target
Drug / intervention
Neoantigen mRNA Vaccinebiological
Likely dose
Not stated in record
Key inclusion· 5
  • Advanced cancer diagnosis
  • Life expectancy greater than 12 weeks
  • Adequate cardiac, pulmonary, hepatic, renal, and hematologic function
  • Available high quality vaccine for human use
Key exclusion· 8
  • Prior gene therapy
  • Severe viral infections including HBV, HCV, or HIV
  • Known HIV positive status
  • Active infectious disease (bacterial, viral, fungal)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06195384
NCT06195384Phase 1RecruitingOn TrackUpdated 24mo ago

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

Second Affiliated Hospital of Guangzhou Medical University·interventional·Posted Jan 8, 2024·Updated Jun 26, 2024

In Brief

A Phase 1 clinical trial evaluating Neoantigen mRNA Vaccine for Solid Tumor, Adult. Currently recruiting, targeting 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 1Recruiting
202420252026202720282029203020312032203320342035203620372038
First PostedJan 8, 2024
Enrollment StartMay 8, 2024
Primary CompletionDec 30, 2027
Study CompletionDec 30, 2037
TodayJul 1, 2026
Enrollment to primary: 3.6 yearsPosted 2.5 years agoPrimary completion in 1.5 years

Interventions

Neoantigen mRNA Vaccinebiological

Deliver neoantigen mRNA vaccine into patients for anti-ancer therapy.