NCT07067385

Personalized mRNA Cancer Vaccine for Gastrointestinal Solid Tumor Treatment

Exploratory Clinical Study of Neoantigen Tumor Vaccine Therapy for Gastrointestinal Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluating the efficacy and safety of Neoantigen Personalized Cancer Vaccine deepGeneAI-001 in combination with Sintilimab in the treatment of Gastrointestinal Solid Tumors

Detailed description

This is a single-center, open, single-arm exploratory clinical study to evaluate the efficacy and safety of Neoantigen Personalized Cancer Vaccine deepGeneAI-001 in combination with Sintilimab in the treatment of Gastrointestinal Solid Tumors, and to provide more clinical treatment options for gastrointestinal cancer patients.

Conditions

• Personalized Neoantigen Vaccine in Combination With Anti-PD-1 Inhibitors in Standard Therapy-Failed and Adjuvant Therapy
• Gastrointestinal Tumors

Interventions

Type	Name	Description
BIOLOGICAL	Neoantigen Personalized Cancer Vaccine	Cohort 1: subjects will receive neoantigen tumor vaccine combination with Sintilimab. Cohort 2: subjects will receive neoantigen tumor vaccine combination with Sintilimab and chemotherapy .

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-07-16
• Last updated: 2025-07-16

Locations

1 site across 1 country: China