Personalized mRNA Cancer Vaccine for Gastrointestinal Solid Tumor Treatment

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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

Eligibility criteria

Qualifiers

Voluntarily signs the informed consent form, and has good compliance.

Male or female, aged 18 years or older.

Patients with advanced gastrointestinal tumors: histologically and/or cytologically confirmed recurrent or metastatic gastrointestinal solid tumors not amenable to surgical or local curative treatment, with at least one measurable lesion as defined by RECIST v1.1. Eligible patients must have experienced disease progression following standard antitumor therapy or be unable or unwilling to receive standard treatment.

Neoantigen load requirement: at least 10 predicted neoantigen epitopes.

Disqualifiers

ECOG performance status of 0 or 1.

Life expectancy of at least 6 months.

Women of childbearing potential include premenopausal women and those within 2 years post-menopause.

A negative serum pregnancy test is required within 7 days before the first dose of the investigational product.

Trial design

Treatments tested in this trial

  • Neoantigen Personalized Cancer Vaccine

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Ruijin Hospital

Lead sponsor

deepGeneAI

Collaborator

Bio-X Institutes, Shanghai Jiao Tong University

Collaborator