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Trial Title:
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen Alone in Subjects With Advanced Digestive System Neoplasms
NCT ID:
NCT06019702
Condition:
Digestive System Neoplasms
Conditions: Official terms:
Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Conditions: Keywords:
iNeo-Vac-R01
Personalized mRNA Vaccine
Neoantigen
Digestive System Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
iNeo-Vac-R01
Description:
Personalized mRNA vaccine encoding neoantigen, IH injection
Arm group label:
Personalized mRNA Vaccine iNeo-Vac-R01
Summary:
The purpose of this study is to assess the safety, feasibility, and efficacy of
personalized mRNA vaccine iNeo-Vac-R01 alone in subjects with advanced digestive system
neoplasms.
Detailed description:
This is a multi-part single-center, open-label, single-arm clinical study of personalized
mRNA vaccine iNeo-Vac-R01 monotherapy in subjects with advanced digestive system
neoplasms. The study will include a dose escalation phase and dose expansion phase. The
traditional 3+3 design will be used in dose escalation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female, >/= 18 years old and /= 6 months.
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 ~ 2.
5. Sufficient tumor tissue samples can be obtained from subjects for genetic analysis,
with at least 2 puncture tissues with a tumor purity of ≥ 50% required for puncture
samples and at least 0.5cm of tissue required for surgical samples. Alternatively,
the original gene sequencing data required for tumor neoantigen analysis can be
provided, including full exon sequencing data of tumor tissue, transcriptome
sequencing data, and full exon sequencing data of peripheral blood.
6. Echocardiographic evaluation: left ventricular ejection fraction (LVEF) >/= 50%.
7. The organ function level must meet the following requirements: absolute neutrophil
count (ANC) >/= 1.5 × 10^9/L, platelet count (PLT) >/= 80 × 10^9/L, hemoglobin (Hb)
>/= 90 g/L; serum total bilirubin (TBIL) /=
28g/L, serum creatinine /= 50mL/min,
prothrombin time (PT) and activated partial thromboplastin time (APTT) and
international standardized ratio (INR) /= grade 3, heart failure within 8 weeks before the first dose of
iNeo-Vac-R01 (New York Heart Association [NYHA] cardiac function >/= grade II,
myocardial infarction, unstable angina, stroke, transient ischemic attack, cardiac
surgery (including coronary artery bypass grafting or percutaneous coronary
intervention) within 8 weeks before the first dose of iNeo-Vac-R01, concomitant
severe electrocardiogram abnormalities (such as ventricular flutter, ventricular
fibrillation, multiform ventricular tachycardia, sick sinus syndrome, third degree
atrioventricular block without pacemaker treatment, QTc >/= 480ms, and other
conditions evaluated by the investigators as severe abnormalities), hypertension
with poor drug control (systolic blood pressure >/= 160mmHg and/or diastolic blood
pressure >/= 100mmHg), or other cardiocerebrovascular diseases that have been
evaluated by the investigators as unsuitable for participation in this trial.
12. Subjects with respiratory disease: previously or currently pulmonary fibrosis,
interstitial lung disease, pneumoconiosis, radiation pneumonia, drug-related
pneumonia, severe asthma, pulmonary hypertension or severe impairment of lung
function, etc.
13. Subjects with moderate to severe ascites with clinical symptoms; uncontrolled or
moderate to equal amounts of pleural effusion and pericardial effusion.
14. Subjects with drug abuse; clinical or psychological or social factors that affect
informed consent or research implementation.
15. Subjects with a history of allergies to immunotherapy or vaccines, or other
potential immunotherapy allergies identified by the investigators.
16. Subjects identified that it is not suitable for enrollment or may not be able to
complete this experiment for other reasons by the investigators.
17. Vulnerable groups, including individuals with mental illness, cognitive impairment,
critical patients, minors, pregnant or lactating women, etc.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiujun Cai, MD
Phone:
0086-0571-86006605
Email:
caixiujunzju@yahoo.com.cn
Start date:
September 8, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Sir Run Run Shaw Hospital
Agency class:
Other
Collaborator:
Agency:
Hangzhou Neoantigen Therapeutics Co., Ltd.
Agency class:
Industry
Source:
Sir Run Run Shaw Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06019702
