NCT07510308

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-11-01
• Completion: 2027-10-01
• First posted: 2026-04-03
• Last updated: 2026-04-13

Locations

2 sites across 1 country: China