Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Subjects With Resected Digestive System Neoplasms

Program Status

Recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

Immunotherapy trial in China, admits patients with  advanced (locally advanced or metastatic) colorectal cancer that can be radically resected.
After surgery, patients will receive a personalized mRNA vaccine iNeo-Vac-R01 with standard of care adjuvant therapy.

Location Location Status
China
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
Hangzhou, Zhejiang 310000
Recruiting

Contacts

Inclusion Criteria

Inclusion Criteria:

Male or female, >/= 18 years old and </= 75 years old, with the ability to understand and provide signed and witnessed informed consent, and agree and are able to comply with protocol requirements.

Subjects must have one of the histologically- or cytologically-confirmed advanced (locally advanced or metastatic) digestive system neoplasms listed below that can be radical resected. Subjects must be able to receive at least 4 cycles of standard adjuvant therapy according to CSCO clinical guidelines after surgery. The toxic effects of previous anti-tumor treatments have returned to /= 6 months.
ECOG performance status score of 0 ~ 1.
Sufficient tumor tissue samples can be obtained from subjects for genetic analysis, with at least 0.5cm*0.5cm of tissue required for surgical samples.
Echocardiographic evaluation: left ventricular ejection fraction (LVEF) >/= 50%.
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) </= 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) </= 2.5 × ULN (if there is liver metastasis, TBIL </= 3 × ULN, AST, ALT /= 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.
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.
Subjects with moderate to severe ascites with clinical symptoms; uncontrolled or moderate to equal amounts of pleural effusion and pericardial effusion.
Subjects with drug abuse; clinical or psychological or social factors that affect informed consent or research implementation.
Subjects with a history of allergies to immunotherapy or vaccines, or other potential immunotherapy allergies identified by the investigators.
Subjects identified that it is not suitable for enrollment or may not be able to complete this experiment for other reasons by the investigators.
Vulnerable groups, including individuals with mental illness, cognitive impairment, critical patients, minors, pregnant or lactating women, etc.

NCT ID

NCT06026774

Date Trial Added

2023-09-07

Updated Date

2023-09-11