Personalized T-Cell Therapy iNeo-Vac-T01 in Advanced Colorectal Cancer

NCT07504523 | Recruiting Phase 1 DMC

• 1 other identifier: 2022-0730
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metastatic Colorectal Cancer (CRC)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Overall Response Rate (ORR)

  36 months

• Progression-Free Survival (PFS)

  36 months

• Neoantigen-specific T-cell immune response

  6 months

• T-cell subset analysis

  6 months

• Cytokines analysis

  6 months

Study Arms (1)

iNeo-Vac-T01 group

EXPERIMENTAL

iNeo-Vac-T01

Biological: iNeo-Vac-T01

Interventions

iNeo-Vac-T01 BIOLOGICAL

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.

iNeo-Vac-T01 group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 years and ≤ 70 years;
• Patients with pathologically and radiologically confirmed advanced colorectal cancer, with at least one measurable lesion on imaging;
• Failure of standard therapy, ineligibility for standard therapy, or refusal to receive standard therapy;
• Expected survival of at least 6 months;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• 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;
• Normal function of major organs including heart, liver, and kidney;
• Normal hematological parameters:
• Neutrophil count ≥ 1.5 × 10⁹/L Hemoglobin ≥ 10 g/dL Platelet count ≥ 100 × 10⁹/L
• 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
• 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.
• Male patients willing to use appropriate contraceptive measures;
• Ability to comply with the study protocol and follow-up procedures.

You may not qualify if:

• Unwilling to sign the informed consent form.
• 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.
• No actionable neoantigens identified for personalized immunotherapy after sequencing data analysis.
• History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation.
• Concomitant use of any other anticancer drugs, investigational anticancer therapy, or immunosuppressive agents; long-term use of systemic glucocorticoids.
• 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.
• Received other vaccinations within 4 weeks prior to treatment (except COVID-19 vaccine).
• Clinically confirmed active bacterial or fungal infection; active tuberculosis or history of tuberculosis.
• 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.
• Severe asthma, autoimmune disease, or immunodeficiency requiring immunosuppressive therapy.
• Excluded: vitiligo, type 1 diabetes, autoimmune hypothyroidism controlled by hormones, psoriasis not requiring systemic therapy.
• Known history of primary immunodeficiency.
• History of psychiatric disorder.

Sponsors & Collaborators

• Ying Yuan, MD: lead
• Hangzhou Neoantigen Therapeutics Co., Ltd.: collaborator

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Ying Yuan

CONTACT

057187784718; yuanying1999@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician，Director，Principal Investigator

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: April 1, 2026
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)