Personalized T-Cell Therapy iNeo-Vac-T01 in 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

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Colorectal Cancer (CRC)
• Intervention / Treatment: Biological: iNeo-Vac-T01

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ying Yuan; Phone Number: 057187784718; Email: yuanying1999@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: iNeo-Vac-T01 group; iNeo-Vac-T01

Biological: iNeo-Vac-T01; iNeo-Vac-T01 Injection is an individually customized tumor neoantigen-specific T cell injection. DNA and RNA sequencing is performed on the tumor tissue of each subject to analyze and predict the tumor neoantigens presented by tumor cells. Meanwhile, the subject's own peripheral blood is collected, and neoantigen-specific T cells are obtained through isolation and culture, then reinfused into the subject. These specific T cells recognize and kill tumor cells expressing the corresponding neoantigens, thereby achieving the goal of inhibiting tumor growth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility:Ratio of patients receiving iNeo-Vac-T01 infusion to total enrolled patients	Ratio of patients receiving iNeo-Vac-T01 infusion to total enrolled patients.	36months
Safety and tolerable dose	Number of subjects with adverse events and/or dose-limiting toxicities in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, which serves as an indicator for evaluating the safety and tolerable dose of iNeo-Vac-T01 injection, with an observation period of approximately 6 months during the dose-escalation phase.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	Evaluation of overall response (OR) based on changes in target lesions per RECIST v1.1, including Complete Response (CR, proportion of patients with disappearance of all target lesions) and Partial Response (PR, proportion of patients with a ≥30% reduction in the sum of the longest diameters of target lesions).	36 months
Progression-Free Survival (PFS)	Time from the date of the first iNeo-Vac-T01 injection infusion to the date of disease progression or death due to any cause, with an evaluation period of 3 years.	36 months
Neoantigen-specific T-cell immune response	Detection of the secretion level of specific TNF-γ in peripheral blood of subjects by ELISpot assay, mainly for observing specific T-cell responses, with an evaluation period of 6 months.	6 months
T-cell subset analysis	Proportions of CD8+, CD4+ and other T-cell subsets within T cells, detected by flow cytometry, mainly for assessing the immune status of patients, with an evaluation period of 6 months.	6 months
Cytokines analysis	Changes in interleukin-6 (IL-6), interleukin-10 (IL-10) and tumor necrosis factor-α (TNF-α) in peripheral blood, with an evaluation period of 6 months.	6 months

Collaborators and Investigators

• Sponsor: Ying Yuan, MD
• Collaborators: Hangzhou Neoantigen Therapeutics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2022-0730

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No