Actively Recruiting
Personalized T-Cell Therapy iNeo-Vac-T01 in Advanced Colorectal Cancer
Led by Ying Yuan, MD · Updated on 2026-04-01
20
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
Sponsors
Y
Ying Yuan, MD
Lead Sponsor
H
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of this study is to evaluate the feasibility, safety, and efficacy of personalized T-cell therapy based on tumor neoantigens in patients with advanced colorectal cancer, so as to provide a novel individualized therapeutic strategy for such patients.
CONDITIONS
Official Title
Personalized T-Cell Therapy iNeo-Vac-T01 in Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years
- Diagnosed with advanced colorectal cancer confirmed by pathology and imaging, with at least one measurable lesion
- Have failed standard therapy, are not eligible for standard therapy, or have refused standard therapy
- Expected to live at least 6 months
- ECOG performance status score between 0 and 1
- Have sufficient tumor tissue for genomic analysis or existing sequencing data meeting requirements
- Normal heart, liver, and kidney function
- Normal blood counts: neutrophils ≥ 1.5 x 10^9/L, hemoglobin ≥ 10 g/dL, platelets ≥ 100 x 10^9/L
- Normal biochemistry: total bilirubin ≤ 1.5 times upper limit of normal (ULN), AST and ALT ≤ 2.5 times ULN; higher limits allowed if liver metastasis present; serum creatinine and BUN ≤ 1.5 times ULN
- For women of childbearing potential: negative pregnancy test within 7 days before enrollment, no plans to become pregnant soon, and willingness to use effective contraception during the study
- Male patients willing to use appropriate contraception
- Ability to follow study protocol and attend follow-up visits
You will not qualify if you...
- Unwilling to sign informed consent
- Having another active cancer except cured basal cell carcinoma, thyroid cancer, cervical dysplasia, or disease-free for >5 years with low recurrence risk
- No actionable neoantigens identified from sequencing
- History of bone marrow or organ transplantation
- Using other anticancer drugs, investigational therapies, immunosuppressants, or long-term systemic steroids
- Symptomatic or untreated brain or central nervous system metastases (stable treated brain metastases allowed)
- Received other vaccinations within 4 weeks prior to treatment (except COVID-19 vaccine)
- Active bacterial, fungal infection, tuberculosis, or history of tuberculosis
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with abnormal viral loads
- Severe asthma, autoimmune diseases, or immunodeficiency requiring immunosuppressive therapy (certain controlled autoimmune diseases excluded)
- Known primary immunodeficiency
- History of psychiatric disorders
- Uncontrolled serious health conditions such as infections, heart failure, unstable angina, arrhythmia, severe coronary or cerebrovascular disease
- Substance abuse or factors compromising informed consent or compliance
- History of severe allergies to foods, drugs, vaccines, or immunotherapy
- Considered ineligible or unlikely to complete the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
Y
Ying Yuan
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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