Actively Recruiting
Evaluation of Feasibility, Safety, and Efficacy of Tumor Neoantigen-Based Personalized T-Cell Therapy iNeo-Vac-T01 in Patients With Advanced Colorectal Cancer
Led by Ying Yuan, MD · Updated on 2026-04-01
20
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating a personalized T-cell therapy called iNeo-Vac-T01 in patients with advanced colorectal cancer. This Phase 1 study aims to assess the feasibility, safety, and effectiveness of this novel individualized treatment by targeting tumor neoantigens to provide a new option for patients who have limited standard therapy choices. The investigational treatment involves tailoring T cells to each patient's tumor by analyzing tumor DNA and RNA to identify specific neoantigens. The patient's own blood is then used to isolate and grow T cells that recognize these neoantigens, which are reinfused to attack cancer cells. This therapy is given as an infusion, with ongoing monitoring over 36 months, including immune response and tumor control evaluations. Participants will undergo tumor tissue genomic analysis and blood collection. Researchers will monitor safety, dose tolerance, immune responses, and tumor progression using imaging and laboratory tests. Follow-up assessments will occur over three years to track treatment feasibility, side effects, and cancer outcomes. The study includes regular evaluations of T-cell activity and cytokine levels within six months after treatment.
CONDITIONS
Brief 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
- Failed, ineligible for, or refused standard therapy
- Expected survival time of at least 6 months
- ECOG performance status score of 0 or 1
- Available tumor tissue sample or existing genomic sequencing data for analysis
- Normal heart, liver, and kidney function
- Normal blood parameters: neutrophil count ≥ 1.5 × 10⁹/L, hemoglobin ≥ 10 g/dL, platelet count ≥ 100 × 10⁹/L
- Normal biochemical parameters within specified limits
- For women of childbearing potential: negative pregnancy test within 7 days before enrollment and commitment to use effective contraception
- Male patients willing to use appropriate contraception
- Ability to comply with study protocol and follow-up
You will not qualify if you...
- Unwilling to sign informed consent
- Having other active cancers except certain cured or low-risk types
- No actionable neoantigens found for personalized therapy after sequencing
- History of bone marrow or organ transplantation
- Use of other anticancer drugs, investigational therapies, immunosuppressants, or long-term systemic steroids
- Symptomatic or untreated brain or central nervous system metastases, except stable treated cases
- Vaccination within 4 weeks before treatment (except COVID-19 vaccine)
- Active bacterial, fungal, or tuberculosis infection
- Positive tests for hepatitis B or C, HIV, or syphilis with abnormal viral loads
- Severe asthma, autoimmune diseases needing immunosuppression, or primary immunodeficiency
- History of psychiatric disorders
- Uncontrolled serious health conditions such as heart failure or severe coronary disease
- Substance abuse or factors affecting consent or compliance
- History of severe allergy to food, drugs, vaccines, or immunotherapy
- Any other condition deemed ineligible by the investigator
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 36 months
Participants receive personalized iNeo-Vac-T01 T-cell therapy designed to target their tumor neoantigens.
Visits scheduled as needed for infusion and monitoring
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
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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