Personalized T-cell Therapy iNeo-Vac-T01 for Advanced Colorectal Cancer

Evaluation of Feasibility, Safety, and Efficacy of Tumor Neoantigen-Based Personalized T-Cell Therapy iNeo-Vac-T01 in Patients With Advanced Colorectal Cancer

This will test a personalized T-cell therapy called iNeo-Vac-T01 in adults with advanced or metastatic colorectal cancer who have not responded to standard treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07504523 on ClinicalTrials.gov

What this trial studies

This Phase 1 trial uses each patient's tumor genomic data to identify neoantigens and generate a personalized T-cell product (iNeo-Vac-T01) intended to target those tumor-specific mutations. Participants must provide tumor tissue or existing sequencing data so neoantigen targets can be identified and the T cells manufactured and expanded. The trial's primary goals are to determine whether the personalized therapy can be produced and delivered safely, with secondary endpoints looking for signs of tumor response. Eligible patients are adults with measurable metastatic colorectal cancer who have failed or are ineligible for standard therapies and have adequate organ and blood function.

Who should consider this trial

Good fit: Adults age 18–70 with pathologically confirmed metastatic colorectal cancer, at least one measurable lesion, ECOG 0–1, adequate organ and blood function, available tumor tissue or sequencing data, and prior failure, ineligibility for, or refusal of standard therapies.

Not a fit: Patients with poor performance status, major organ dysfunction, insufficient tumor tissue or sequencing data, or very limited life expectancy are unlikely to benefit from this early-phase experimental therapy.

Why it matters

Potential benefit: If successful, the approach could offer a personalized immune therapy that shrinks tumors or slows progression in patients with advanced colorectal cancer who have few remaining treatment options.

How similar studies have performed: Early-phase neoantigen-targeted T-cell and vaccine approaches have generated immune responses and occasional tumor shrinkage in other cancers, but such personalized therapies remain experimental and have had limited evidence of success specifically in colorectal cancer.

Eligibility criteria

Inclusion Criteria

1. Aged ≥ 18 years and ≤ 70 years;
2. Patients with pathologically and radiologically confirmed advanced colorectal cancer, with at least one measurable lesion on imaging;
3. Failure of standard therapy, ineligibility for standard therapy, or refusal to receive standard therapy;
4. Expected survival of at least 6 months;
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
6. Sufficient tumor tissue sample available for genomic analysis, or existing whole-genome/whole-exome/transcriptome sequencing data of tumor and normal tissues that meet analytical requirements;
7. Normal function of major organs including heart, liver, and kidney;
8. Normal hematological parameters:

   Neutrophil count ≥ 1.5 × 10⁹/L Hemoglobin ≥ 10 g/dL Platelet count ≥ 100 × 10⁹/L
9. Normal biochemical parameters:

   Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ≤ 3 × ULN allowed in patients with liver metastasis AST and ALT ≤ 2.5 × ULN; ≤ 5 × ULN allowed in patients with liver metastasis Serum creatinine and blood urea nitrogen (BUN) ≤ 1.5 × ULN
10. For women of childbearing potential:

    negative pregnancy test within 7 days before enrollment, no intention to become pregnant in the near term, and willingness to use effective contraception during the study; Pregnant or lactating women are excluded.
11. Male patients willing to use appropriate contraceptive measures;
12. Ability to comply with the study protocol and follow-up procedures.

Exclusion Criteria

1. Unwilling to sign the informed consent form.
2. Concurrent malignancy other than the following:

   cured basal cell carcinoma, thyroid cancer, cervical dysplasia, and disease-free for more than 5 years with low risk of recurrence in the investigator's judgment.
3. No actionable neoantigens identified for personalized immunotherapy after sequencing data analysis.
4. History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation.
5. Concomitant use of any other anticancer drugs, investigational anticancer therapy, or immunosuppressive agents; long-term use of systemic glucocorticoids.
6. Symptomatic or untreated known brain metastasis or other central nervous system (CNS) metastases.

   Patients with completely resected and/or irradiated CNS metastases that are stable or improved (radiologically stable for at least 4 weeks prior to randomization by CT/MRI, no evidence of cerebral edema, and no requirement for glucocorticoids or anticonvulsants) are eligible.
7. Received other vaccinations within 4 weeks prior to treatment (except COVID-19 vaccine).
8. Clinically confirmed active bacterial or fungal infection; active tuberculosis or history of tuberculosis.
9. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the normal range; positive hepatitis C virus (HCV) antibody with peripheral blood HCV RNA above the normal range; positive human immunodeficiency virus (HIV) antibody; positive syphilis test.
10. Severe asthma, autoimmune disease, or immunodeficiency requiring immunosuppressive therapy.

    Excluded: vitiligo, type 1 diabetes, autoimmune hypothyroidism controlled by hormones, psoriasis not requiring systemic therapy.
11. Known history of primary immunodeficiency.
12. History of psychiatric disorder.
13. Uncontrolled comorbidities including but not limited to:

    active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia; severe coronary artery disease or cerebrovascular disease; or other conditions deemed ineligible by the investigator.
14. Substance abuse, or clinical, psychological, or social factors that would compromise informed consent or compliance with the study.
15. History of severe allergy to food, drugs, or vaccines, or other potential allergy to immunotherapy in the investigator's judgment.
16. Patients considered ineligible by the investigator or unlikely to complete the study for other reasons.

Where this trial is running

Hangzhou, Zhejiang

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Ying Yuan

Conditions Metastatic Colorectal Cancer