Personalized mRNA Cancer Vaccine for Gastrointestinal Solid Tumor Treatment

NCT07067385 | Recruiting Phase 1

• 1 other identifier: JZ202401
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

neoantigen; p-MHC-TCR; CRC; mRNA; machine learning

Outcome Measures

Primary Outcomes (3)

• Adverse events as graded by CTCAE v5.0

  Up to 2.5 years

• Serious adverse events as graded by CTCAE v5.0

  Up to 2.5 years

• Immunogenicity of a personalized cancer vaccine as measured by interferon-γ secreting T lymphocytes in peripheral blood mononuclear cells (PBMCs) using ELISpot

  Up to 2.5 years

Secondary Outcomes (7)

• Cohort 1: Objective Response Rate (ORR) by RECIST 1.1

  Up to 2.5 years

• Cohort 1: Duration of Response (DOR)

  Up to 2.5 years

• Cohort 1: Disease Control Rate (DCR)

  Up to 2.5 years

• Cohort 1: Progression Free Survival (PFS) as assessed by RECIST 1.1

  Up to 2.5 years

• Cohort 1: Overall Survival (OS)

  Up to 2.5 years

Study Arms (1)

Neoantigen Personalized Cancer Vaccine

EXPERIMENTAL

Cohort 1: Salvage Therapy ; Cohort 2: Adjuvant Therapy

Biological: Neoantigen Personalized Cancer Vaccine

Interventions

Neoantigen Personalized Cancer Vaccine BIOLOGICAL

Cohort 1: subjects will receive neoantigen tumor vaccine combination with Sintilimab. Cohort 2: subjects will receive neoantigen tumor vaccine combination with Sintilimab and chemotherapy .

Also known as: deepGeneAI-001

Neoantigen Personalized Cancer Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients with resectable gastrointestinal solid tumors for adjuvant treatment: tumors must be confirmed as completely resected (R0 or R1) by postoperative histopathology, with no prior neoadjuvant therapy, and assessed as fully resectable by imaging.
• Neoantigen load requirement: at least 10 predicted neoantigen epitopes.

You may not qualify if:

• ECOG performance status of 0 or 1.
• Life expectancy of at least 6 months.
• Adequate organ and hematologic function, with no severe dysfunction of the heart, lungs, liver, kidneys, or immune system, based on the following laboratory values:
• ). Hematology: ANC ≥ 1.5 × 10⁹/L, WBC ≥ 3 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L. Within one week before screening, the subject must not have received blood or platelet transfusions, G-CSF, or erythropoietin (EPO); 2). Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula); 3). Liver function: AST and ALT ≤ 3 × ULN (≤ 5 × ULN for patients with liver cancer or liver metastases); TBIL ≤ 1.5 × ULN (patients with Gilbert's syndrome: TBIL \< 3 × ULN); 4). Coagulation: INR ≤ 2 × ULN or APTT ≤ 1.5 × ULN (except for patients on anticoagulants); 5). Endocrine function: TSH within normal limits. Note: If baseline TSH is outside the normal range but free T3 and free T4 are within normal limits, the subject is still eligible.
• \. Agrees to provide peripheral blood samples and, optionally, fresh peritumoral tissue for sequencing.
• \. Male subjects with reproductive potential and female subjects of childbearing potential agree to use effective contraception from the time of informed consent until 6 months after the last dose of investigational drug.
• 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.
• Known allergy or hypersensitivity to any investigational drug or its components used in this study.
• Use of high-dose corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days before the first dose of study drug.
• Receipt of the following therapies or interventions within 28 days before the first dose of study drug:
• Participation in an interventional clinical study;
• Major surgery or traumatic injury, or expected to undergo major surgery during the study (minor procedures such as core needle biopsy or placement of a vascular access device within 7 days before the first dose are permitted);
• Vaccination with a live attenuated vaccine, or planned vaccination during the study or within 5 months after the last dose of study treatment;
• Systemic antitumor therapy (including chemotherapy, small molecule targeted therapy, antibody therapy, cellular immunotherapy, hormonal therapy), or local antitumor therapy (e.g., radiotherapy). Palliative radiotherapy for bone metastases completed \>2 weeks before baseline tumor assessment is allowed. Also includes prior treatment with systemic immune-stimulating agents (e.g., interferons or interleukin-2).

Sponsors & Collaborators

• Ruijin Hospital: lead
• deepGeneAI: collaborator
• Bio-X Institutes, Shanghai Jiao Tong University: collaborator

Study Sites (1)

Ruijin Hospital

Shanghai, SH, China

RECRUITING

MeSH Terms

Conditions

Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases

Study Officials

• Hao Li

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Li, MD, PhD

CONTACT

86-15000660260; lh11001@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 16, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)