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pMMR/MSS Advanced Colorectal CancerPhase 1NCT07510308

Clinical Study of MSH2-/- Tumor Cell Vaccines for Advanced pMMR Colorectal Cancer Patients

A Phase 1 study testing Low Dose MSH2-/- tumor cell vaccine, Medium Dose MSH2-/- tumor cell vaccine and High dose MSH2-/- tumor cell vaccine in people with pMMR/MSS Advanced Colorectal Cancer, run by West China Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to evaluate the safety and tolerability of an MSH2-/- tumor cell vaccine and to explore its preliminary antitumor activity and immunogenicity in adults with advanced proficient mismatch repair (pMMR) colorectal cancer who have failed, are intolerant of, or decline standard systemic… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
pMMR/MSS Advanced Colorectal Cancer
What is being tested?
Low Dose MSH2-/- tumor cell vaccine, Medium Dose MSH2-/- tumor cell vaccine and High dose MSH2-/- tumor cell vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
2 sitesChina
Study dates
11 Jun 2026to 1 Oct 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 to 75 years at the time of acquisition informed consent form.
  • Patients with histologically or cytologically confirmed pMMR colorectal cancer based on molecular typing, who have experienced failure of, are intolerant to, or refuse standard therapy.
  • For patients with RAS/BRAF wild-type disease who are eligible for targeted therapy, enrollment is permitted only after they have previously received standard regimens containing an anti-EGFR monoclonal antibody or an anti-VEGF monoclonal antibody and subsequently experienced disease progression.
  • For patients with a BRAF V600E mutation, enrollment is permitted only after failure of prior treatment with a regimen containing a BRAF inhibitor in combination with chemotherapy.
  • For patients who do not meet the above molecular criteria, enrollment is permitted only after failure of at least two prior lines of systemic chemotherapy, including platinum-based agents.
  • The presence of at least one measurable or evaluable lesion according to RECIST v1.1 criteria.
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  • Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2.
  • Predicted survival time ≥3 months.
  • The main organs are functioning well and the following requirements are met within 7 days before receiving treatment:
  • ① Hemoglobin (HGB) ≥80 g/L (no blood transfusion within 14 days); Absolute neutrophil count (ANC) >1.5×109/L; White blood cell count ≥3.0×109/L; Platelet count (PLT) ≥80×109/L;
  • ② Total bilirubin ≤1.5× upper limit of normal value (ULN); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5×ULN; If there was liver metastasis, ALT or AST≤5×ULN;
  • ③ Creatinine (SCr) ≤1.5×ULN or creatinine clearance (CRCI) estimated by Cockcroft-Gault formula ≥60 mL/min;
  • ④ Prothrombin time (PT), international normalized ratio (INR) ≤1.5×ULN (unless anticoagulation with warfarin);
  • ⑤ Cardiac function: left ventricular ejection fraction ≥50%. QTcF interval ≤450 ms.
  • Men of childbearing potential and women of childbearing age voluntarily use effective contraceptive methods (e.g., condoms, intrauterine devices, spermicides) from the time of signing the informed form until 6 months after the completion of vaccination, and contraceptive use is not allowed. Female cancer patients who have a negative pregnancy test and agree not to breastfeed during the study and for at least 18 months after receipt of the trial vaccine;
  • The washout period of previous anti-tumor therapy should be at least 4 weeks, and the washout period of molecular targeted drugs should be at least 5 half-lives. Palliative radiotherapy needs to have been completed for at least 2 weeks; Chest radiation therapy needed to have been completed for at least 3 months, and major surgery needed to have been completed with at least 4 weeks of recovery.

Who cannot join

  • The patient has a history of other tumors in the past, except for the history of malignant tumors that have been cured and have not recurred within 5 years before screening, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer in situ, and intramucosal cancer of the gastrointestinal tract, which the investigator considers to be eligible for enrollment.
  • Have any uncontrolled clinical diseases (e.g., diseases of the respiratory system, circulatory system, digestive system, nervous system, hematologic system, urogenital system, endocrine system) or psychiatric or other major medical condition that the investigator considers to interfere with the provision of informed consent, to interfere with the interpretation of the trial results, to pose a risk to the study participants, or to otherwise interfere with the achievement of the study objectives.
  • Have any active autoimmune disease or a history of autoimmune disease. Participants with asthma for which medical intervention with bronchodilators was required could not be included.
  • Allergy to the trial drug (including any excipients). Previous history of severe allergy to any drug, food or vaccination, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.
  • There are contraindications to subcutaneous injection.
  • Received prior antitumor therapeutic vaccine or cellular immunotherapy.
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  • Participated in other drug or device clinical trials 4 weeks before screening.
  • Study participants on systemic therapy with corticosteroids (>10 mg/ day of prednisone or equivalent doses of other glucocorticoids) or other immunosuppressive agents within 14 days before the first dose of vaccine. Inhaled or topical steroids and adrenal hormone replacement at a therapeutic dose of prednisone of 10 mg or less per day were allowed in the absence of active autoimmune disease.
  • Before the first dose of the study drug. Any toxic effects from previous antineoplastic therapy have not recovered to NCI CTCAE grade 5.0 ≤1 (any degree of alopecia, other than grade 2 previous platinum-based treatment-related neuropathy).
  • Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
  • Have a history of substance abuse or known medical, psychological, or social conditions such as alcohol or drug abuse.
  • Have received any vaccine within 30 days before receiving the study vaccine or plan to receive any vaccine other than the study vaccine during the study.
  • The presence of any other factor that was deemed by the investigator to preclude study participant entry into the trial or that study participant had any medical condition that could interfere with the assessment of the safety or efficacy of the study treatment.
  • Study participants who were unwilling or unable to comply with study requirements.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xingchen Peng, Ph.D contact

+8618980606753

pxx2014@163.com

China2 sites, 2 recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    XingChen Peng, Ph.D, +86 18980606753, pxx2014@scu.edu.cn

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

    Recruiting

Other trials in China

About this study

Official title: A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Antitumor Activity of MSH2-/- Tumor Cell Vaccines in Patients With Advanced pMMR Colorectal Cancer.

The goal of this clinical trial is to evaluate the safety and tolerability of an MSH2-/- tumor cell vaccine and to explore its preliminary antitumor activity and immunogenicity in adults with advanced proficient mismatch repair (pMMR) colorectal cancer who have failed, are intolerant of, or decline standard systemic therapies at West China Hospital, Sichuan University. The main objectives are to determine the incidence of dose-limiting toxicities (DLTs) and other treatment-emergent adverse events (TEAEs) related to the vaccine (n/N, %, graded per NCI CTCAE v5.0), to assess preliminary antitumor activity (objective response per RECIST v1.1, progression-free survival, and overall survival), and to characterize the vaccine's immunogenicity profile.

This study using a 3+3 dose-escalation design with three dose levels of the MSH2-/- tumor cell vaccine (1×10^7, 2.5×10^7, and 5×10^7 cells per dose), manufactured under GMP conditions and administered by intradermal injection. Each participant will receive four induction vaccinations (three doses every 2 weeks and a fourth dose 1 month after the third), followed by up to eight booster doses every 4 weeks based on tumor response. Participants will undergo protocol-specified safety monitoring with clinical assessments, laboratory tests, and documentation of all AEs/SAEs, and tumor response will be evaluated regularly by imaging per RECIST v1.1. After treatment completion or discontinuation, participants will enter safety and long-term follow-up for disease status and survival.

Being tested
Low Dose MSH2-/- tumor cell vaccine, Medium Dose MSH2-/- tumor cell vaccine, High dose MSH2-/- tumor cell vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Dose MSH2-/- tumor cell vaccineBiological

    Participants were assigned to receive the MSH2-/- tumor cell vaccine in the number of 1x10e7 tumor cells per dose.

  • Medium Dose MSH2-/- tumor cell vaccineBiological

    Patients will receive the MSH2-/- tumor cell vaccine in the number of 2.5x10e7 tumor cells per dose.

  • High dose MSH2-/- tumor cell vaccineBiological

    Patients will receive the MSH2-/- tumor cell vaccine in the number of 5x10e7 tumor cells per dose.

Study groups in NCT07510308
Study groupRoleWhat they receive
MSH2-/- Tumor Cell Vaccine (Low Dose )ExperimentalParticipants receive the MSH2-/- tumor cell vaccine at a dose of 1×10^7 inactivated tumor cells.
Receives: Biological: Low Dose MSH2-/- tumor cell vaccine
MSH2-/- Tumor Cell Vaccine (Medium Dose)ExperimentalParticipants receive the MSH2-/- tumor cell vaccine at a dose of 2.5×10^7 inactivated tumor cells.
Receives: Biological: Medium Dose MSH2-/- tumor cell vaccine
MSH2-/- Tumor Cell Vaccine (High Dose)ExperimentalParticipants receive the MSH2-/- tumor cell vaccine at a dose of 5×10^7 inactivated tumor cells.
Receives: Biological: High dose MSH2-/- tumor cell vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0)

    DLTs are defined as treatment-related adverse events (graded according to NCI-CTCAE v5.0) occurring during the DLT observation period that meet specific protocol-defined criteria for hematologic and non-hematologic toxicity.

    Measured: From the first dose through 14 days following the third dose.

  2. Number of Participants Experienced Treatment-emergent adverse events (TEAEs) according to NCI CTCAE V5.0

    Treatment-emergent adverse events (TEAEs) related to the study drug (including definitely related, probably related, and possibly related), graded according to NCI CTCAE V5.0

    Measured: 12 months

Secondary outcomes (4)

  1. Number of participants achieving complete response (CR) According to Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1

    CR was defined as participants in the analysis population who had a confirmed disappearance of all lesions according to Response Evaluation Criteria in Solid RECIST 1.1

    Measured: 12 months

  2. Number of participants achieving partial response (PR) According to RECIST 1.1

    PR was defined as participants in the analysis population who had a confirmed at least a 30% decrease according to Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1

    Measured: 12 months

  3. Progression Free Survival (PFS) According to RECIST 1.1

    PFS is defined as the duration until disease progression or death in participants from the first dose of immunization.

    Measured: 6 months

  4. Overall Survival(OS)

    OS is defined as the duration until death in participants from the first dose of immunization.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2026
  2. Study start11 Jun 2026
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07510308
Sponsor's protocol ID
2025-2583
Status last verified
Jun 2026
First submitted
17 Mar 2026
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pang K, Sun P, Liu X, Yang D, Zhao P, Huang Y, Cao S, Gao Y, Chen G, Yu H, Duan L, Yang Y, Zhang Z. Development of the rationale of a personalized cancer vaccine based on the in situ vaccine effect of radiotherapy: a mechanistic study of the POLARSTAR trial. Cancer Immunol Immunother. 2025 Nov 12;74(12):369. doi: 10.1007/s00262-025-04229-3.

    PubMed 41222702

  • De Marco L, Micarelli E, Panula J, Nikkola J, Moilanen L, Annala M, Harkonen J, Hokkanen KE, D'Alise AM, Pylvanainen K, Peltomaki PT, Ahtiainen M, Bohm J, Mecklin JP, Scarselli E, Seppala TT. NOUS-209 Off-the-shelf Immunotherapy Has the Potential to Hit Primary and Metachronous Colorectal and Urothelial Cancers in Lynch Syndrome. Mol Cancer Ther. 2026 Apr 2;25(4):650-661. doi: 10.1158/1535-7163.MCT-25-0864.

    PubMed 41232028

  • Li J, Wang P. Advances in Cancer Vaccines for Digestive System Cancers: A Systematic Analysis of Clinical Trials. Cancer Manag Res. 2025 Nov 11;17:2691-2703. doi: 10.2147/CMAR.S561298. eCollection 2025.

    PubMed 41245584

  • Passardi A, Sullo FG, Bittoni A, Matteucci L, De Rosa F, Bulgarelli J, Tazzari M, Petrini M, Scarpi E, Testoni S, Miserocchi A, Tartagni O, Zani C, Iaia ML, Toma I, Viola MG, Mita MT, Tamburini E, Ridolfi L. CombiCoR-Vax trial: study protocol for a phase II, single-arm, multicenter trial of sequential pembrolizumab plus dendritic cell vaccine followed by trifluridine/tipiracil and bevacizumab in refractory microsatellite-stable metastatic colorectal cancer. BMC Cancer. 2025 Nov 22;25(1):1921. doi: 10.1186/s12885-025-15371-7.

    PubMed 41275134

  • Karimzadeh F, Heidari R, Lamooki FM, Soureshjani EH, Aziz S, Mirzaei SA. Design of a multi-epitope vaccine against intestinal parasites associated with colorectal cancer using immunoinformatics approaches. Sci Rep. 2025 Dec 8;16(1):1487. doi: 10.1038/s41598-025-31713-8.

    PubMed 41360964

  • D'Alise AM, Willis J, Duzagac F, Hall MJ, Cruz-Correa M, Idos GE, Thirumurthi S, Ballester V, Leoni G, Garzia I, Antonucci L, De Marco L, Micarelli E, Deng N, Secli L, Gogov S, Dong W, Jack Lee J, Bowen CM, Vornik LA, Garcia-Gonzalez A, Reyes-Uribe L, Richmond E, Umar A, Brown PH, Sinha KM, Rodriguez LM, Scarselli E, Vilar E. Nous-209 neoantigen vaccine for cancer prevention in Lynch syndrome carriers: a phase 1b/2 trial. Nat Med. 2026 Mar;32(3):1002-1011. doi: 10.1038/s41591-025-04182-9. Epub 2026 Jan 16.

    PubMed 41545594

  • Huang J, Tian G. Immunotherapy in advanced colorectal cancer: Current landscape, mechanisms, challenges, and future directions. J Oncol Pharm Pract. 2026 Jan 22:10781552251414845. doi: 10.1177/10781552251414845. Online ahead of print.

    PubMed 41571235

  • Hamdan F, Gandolfi S, D'Alessio F, Giannoula Y, Kolikova J, Fusciello M, Zaghen E, Napolano A, Russo S, Izci O, Bottega P, Chiaro J, Alanen KM, Antignani G, Feodoroff M, Stigzelius V, Sakalauskaite M, Sandberg J, Nieminen AI, Zambrano N, Eriksson O, Mustjoki S, Seppala TT, Gronholm M, Cerullo V. Leveraging glucan-induced trained immunity for the epigenetic and metabolic rewiring of macrophages to enhance colorectal cancer vaccine response. Nat Commun. 2026 Jan 28;17(1):1757. doi: 10.1038/s41467-026-68466-5.

    PubMed 41605920

  • Yang Q, Shi X, Yang K, Gao Q, Cao Y, Huang Y, Chen L, Bao S, Xu L, Reis RL, Kundu SC, Xu H, Xiao B. A manganese-based nanoplatform leveraging chemodynamic and adjuvant effects for in situ vaccination against colorectal cancer. Biomaterials. 2026 Aug;331:124085. doi: 10.1016/j.biomaterials.2026.124085. Epub 2026 Feb 18.

    PubMed 41723903

  • Wang D, Zhang H, Xiang T, Wang G. Clinical Application of Adaptive Immune Therapy in MSS Colorectal Cancer Patients. Front Immunol. 2021 Oct 13;12:762341. doi: 10.3389/fimmu.2021.762341. eCollection 2021.

    PubMed 34721435

  • Keivany MR, Shojae Asrami E, Besharatloo M, Latifi H, Barjasteh AH. Advances in immunotherapy for colorectal cancer: overcoming resistance in mismatch repair-proficient tumors. Cancer Cell Int. 2026 Feb 19;26(1):151. doi: 10.1186/s12935-026-04177-7.

    PubMed 41715188

  • Bolivar AM, Duzagac F, Sinha KM, Vilar E. Advances in vaccine development for cancer prevention and treatment in Lynch Syndrome. Mol Aspects Med. 2023 Oct;93:101204. doi: 10.1016/j.mam.2023.101204. Epub 2023 Jul 19.

    PubMed 37478804

  • Tang TY, Colbert Maresso K, Ngeow J, Vilar E, Yap TA. Germline Mutations as Cancer Drug Targets. Cancer Discov. 2025 Nov 3;15(11):2213-2234. doi: 10.1158/2159-8290.CD-24-1241.

    PubMed 41178351

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Low Dose MSH2-/- tumor cell vaccine, Medium Dose MSH2-/- tumor cell vaccine and High dose MSH2-/- tumor cell vaccine in people with pMMR/MSS Advanced Colorectal Cancer, run by West China Hospital at 2 sites 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 16 inclusion and 14 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 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Xingchen Peng, Ph.D (+8618980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0) (time frame: From the first dose through 14 days following the third dose.). 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?

On the ClinicalTrials.gov record for NCT07510308, which also lists 13 linked publications.

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 30 Jun 2026.

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