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

NCT07510308 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-06-30

No results posted yet for this study

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 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.

Conditions

  • pMMR/MSS Advanced Colorectal Cancer

Interventions

BIOLOGICAL

Low Dose MSH2-/- tumor cell vaccine

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

BIOLOGICAL

Medium Dose MSH2-/- tumor cell vaccine

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

BIOLOGICAL

High dose MSH2-/- tumor cell vaccine

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

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Xingchen Peng, MD · West China Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-11
Primary Completion
2026-11-01
Completion
2027-10-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07510308 on ClinicalTrials.gov