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

ConditionMetastatic Colorectal Cancer (CRC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorYing Yuan, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Unwilling to sign the informed consent form.

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • iNeo-Vac-T01

    Biological/Vaccine

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: iNeo-Vac-T01 groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
36months
2

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.

Time frame
36 months

Secondary outcomes

1

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).

Time frame
36 months
2

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.

Time frame
36 months
3

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.

Time frame
6 months
4

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ying Yuan, MD

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor institution

Hangzhou Neoantigen Therapeutics Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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