Actively Recruiting
A Clinical Study to Assess the Safety, Feasibility, and Efficacy of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard First-line Treatment in Subjects With Advanced Digestive System Neoplasms
Led by Sir Run Run Shaw Hospital · Updated on 2023-09-11
20
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
S
Sir Run Run Shaw Hospital
Lead Sponsor
H
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, and efficacy of a personalized mRNA vaccine called iNeo-Vac-R01 combined with standard first-line treatment in adults with advanced digestive system cancers. This phase 1, single-center, open-label, single-arm study focuses on patients with locally advanced or metastatic digestive system neoplasms who have measurable disease and meet specific health criteria. Participants will first receive at least four cycles of standard first-line treatment following clinical guidelines. After this, they will receive the personalized mRNA vaccine iNeo-Vac-R01 via intramuscular injection on the first day of each 21-day cycle for up to nine cycles at a dose determined during the dose escalation phase. This combination treatment aims to assess both the vaccine's safety and immune response alongside the standard therapy. Throughout the study, participants will undergo evaluations including monitoring for adverse events, tumor response assessments, and immune system measurements such as neoantigen-specific T cell response and cytokine levels. The primary safety outcome will be recorded 21 days after the last vaccine dose, with long-term follow-up of survival and disease control over three years. Other assessments include heart function, organ function tests, and genetic analyses from tumor tissue or sequencing data. The study is expected to continue until the end of 2027.
CONDITIONS
Brief Title
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard First-line Treatment in Subjects With Advanced Digestive System Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years who can understand and sign informed consent and comply with the study protocol
- Histologically or cytologically confirmed advanced (locally advanced or metastatic) digestive system neoplasms with measurable disease per RECIST v1.1
- Completed at least 4 cycles of standard first-line treatment according to clinical guidelines
- Toxic effects of previous anti-tumor treatments returned to grade 1 or lower
- Expected survival of 6 months or longer
- ECOG performance status score of 0 or 1
- Availability of sufficient tumor tissue samples or original gene sequencing data for genetic analysis
- Left ventricular ejection fraction of 50% or higher by echocardiography
- Organ function meeting specified laboratory thresholds for blood counts, liver, kidney, and coagulation parameters
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception or abstain during treatment
- Men must agree to use contraception or abstain during treatment
You will not qualify if you...
- History of cancer requiring anti-tumor treatment within 5 years prior to enrollment, except certain early-stage or treated cancers
- Major surgery, traumatic injury, or untreated wounds/fractures within 2 weeks before first vaccine dose
- No new antigens available for individualized immunotherapy based on sequencing data
- Previous or planned bone marrow or organ transplantation
- Use of other anti-tumor treatments within 2 weeks before first vaccine dose
- Use of immunosuppressants or systemic glucocorticoids within 7 days before first dose (with some exceptions)
- Untreated or symptomatic central nervous system metastases unless stable for at least 4 weeks
- Receipt of other vaccines within 4 weeks before first dose or planned vaccines during treatment or within 60 days after last dose
- Active or uncontrolled infections including tuberculosis
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis beyond normal limits
- Autoimmune diseases treated with immunosuppressives or primary immunodeficiency except certain controlled conditions
- Serious cardiocerebrovascular disease or uncontrolled hypertension
- Severe respiratory diseases or impaired lung function
- Moderate to severe ascites or pleural/pericardial effusion
- Drug abuse or psychological/social factors affecting consent or study participation
- History of allergies to immunotherapy or vaccines
- Other investigator-assessed reasons making participation unsuitable
- Vulnerable groups including mentally ill, cognitively impaired, critically ill, minors, pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 39 weeks (9 cycles of 21 days each) plus duration of standard first-line treatment
Participants receive at least 4 cycles of standard first-line treatment followed by up to 9 cycles of personalized mRNA vaccine iNeo-Vac-R01 via intranodal injection every 21 days.
1 visit every 21 days for vaccine injection, plus visits for standard first-line treatment
Duration - Up to 3 years after first dose of iNeo-Vac-R01
Participants are monitored for safety, immune response, and long-term outcomes after completing treatment.
Periodic visits for up to 3 years including assessments at 6 and 12 months
Trial Site Locations
Total: 1 location
1
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xiujun Cai, MD
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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