Metastatic Colorectal Cancer (CRC)Phase 1NCT07504523
Personalized T-Cell Therapy iNeo-Vac-T01 in Advanced Colorectal Cancer
A Phase 1 study testing iNeo-Vac-T01 in people with Metastatic Colorectal Cancer (CRC), run by Ying Yuan, MD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Colorectal Cancer (CRC)
- What is being tested?
- iNeo-Vac-T01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
- Substance abuse, or clinical, psychological, or social factors that would compromise informed consent or compliance with the study.
- History of severe allergy to food, drugs, or vaccines, or other potential allergy to immunotherapy in the investigator's judgment.
- Patients considered ineligible by the investigator or unlikely to complete the study for other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
About this study
Official title: 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.
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Being tested
- iNeo-Vac-T01
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNeo-Vac-T01Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| iNeo-Vac-T01 group | Experimental | iNeo-Vac-T01 Receives: Biological: iNeo-Vac-T01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 36 months
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Nov 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ying Yuan, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Neoantigen Therapeutics Co., Ltd.
- Responsible party
- Sponsor-investigator, Ying Yuan, MD, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504523
- Sponsor's protocol ID
- 2022-0730
- Status last verified
- Aug 2025
- First submitted
- 22 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Feasibility, Safety, and Efficacy of Tumor Neoantigen-Based Personalized T-Cell Therapy iNeo-Vac-T01 in Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07504523
- Acronym / sponsor ID
- 2022-0730
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ying Yuan, MDUniversity, hospital or other
- Collaborators
- Hangzhou Neoantigen Therapeutics Co., Ltd.
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iNeo-Vac-T01 group | Experimental | Biological: iNeo-Vac-T01iNeo-Vac-T01 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iNeo-Vac-T01iNeo-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. | Biological | iNeo-Vac-T01 group |
Primary outcome
Feasibility:Ratio of patients receiving iNeo-Vac-T01 infusion to total enrolled patients
Time frame: 36months
Ratio of patients receiving iNeo-Vac-T01 infusion to total enrolled patients.
Safety and tolerable dose
Time frame: 36 months
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.
5 secondary outcomes
Overall Response Rate (ORR)
Time frame: 36 months
Progression-Free Survival (PFS)
Time frame: 36 months
Neoantigen-specific T-cell immune response
Time frame: 6 months
T-cell subset analysis
Time frame: 6 months
Cytokines analysis
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing iNeo-Vac-T01 in people with Metastatic Colorectal Cancer (CRC), run by Ying Yuan, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Yuan (057187784718, yuanying1999@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility:Ratio of patients receiving iNeo-Vac-T01 infusion to total enrolled patients (time frame: 36months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.