Actively Recruiting
Personalized mRNA Cancer Vaccine for Gastrointestinal Solid Tumor Treatment
Led by Ruijin Hospital · Updated on 2025-07-16
40
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
D
deepGeneAI
Collaborating Sponsor
AI-Summary
What this Trial Is About
Evaluating the efficacy and safety of Neoantigen Personalized Cancer Vaccine deepGeneAI-001 in combination with Sintilimab in the treatment of Gastrointestinal Solid Tumors
CONDITIONS
Official Title
Personalized mRNA Cancer Vaccine for Gastrointestinal Solid Tumor Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signs the informed consent form and has good compliance
- Male or female aged 18 years or older
- Patients with advanced gastrointestinal solid tumors confirmed by histology or cytology, with at least one measurable lesion, progressed after standard therapy or cannot receive standard treatment
- Patients with resectable gastrointestinal tumors for adjuvant treatment confirmed completely resected by postoperative histopathology, with no prior neoadjuvant therapy
- At least 10 predicted neoantigen epitopes required
- Tumor lesion suitable for repeated sampling for sequencing and immune testing, with acceptable tumor tissue samples available
- ECOG performance status of 0 or 1
- Life expectancy of at least 6 months
- Adequate organ and hematologic function with no severe dysfunction of heart, lungs, liver, kidneys, or immune system
- Agrees to provide peripheral blood samples and optionally fresh peritumoral tissue for sequencing
- Male subjects with reproductive potential and females of childbearing potential agree to use effective contraception until 6 months after last dose
- Negative serum pregnancy test within 7 days before first dose for women of childbearing potential
You will not qualify if you...
- Known allergy or hypersensitivity to investigational drugs or components
- Use of high-dose corticosteroids (>10 mg/day prednisone or equivalent) or immunosuppressive medications within 14 days before first dose
- Participation in other interventional clinical studies within 28 days before first dose
- Major surgery or traumatic injury within 28 days before first dose, except minor procedures within 7 days
- Vaccination with live attenuated vaccine planned or recent within 5 months of last dose
- Recent systemic or local antitumor therapy within 28 days before first dose, except certain palliative radiotherapy
- Severe chronic or active infection within 28 days before first dose or recent systemic antibiotic treatment
- Clinically significant residual toxicity (grade ≥2) from previous treatments, except alopecia or hyperpigmentation
- Presence of CNS metastases or carcinomatous meningitis, unless stable for at least 3 months
- Active infections including hepatitis B, hepatitis C, HIV, tuberculosis, or others requiring systemic treatment
- Significant cardiovascular or cerebrovascular disease within 6 months before first dose
- Active autoimmune diseases requiring systemic treatment within 2 years before first dose
- History of other malignancies within 3 years before study, except certain curatively treated cancers
- Severe or uncontrolled diseases or conditions that may interfere with participation
- Prior allogeneic hematopoietic stem cell or solid organ transplantation
- History of substance abuse or psychiatric disorders interfering with compliance
- Pregnant or breastfeeding women
- Prior treatment with cell therapies, neoantigen-based vaccines, or immune checkpoint inhibitors
- Genetic defects affecting antigen presentation, recognition, or cytotoxicity
- Any other condition deemed inappropriate by investigator for study enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, SH, China
Actively Recruiting
Research Team
H
Hao Li, MD, PhD
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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