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NCT07510308

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

Recruiting now Phase 1 Last updated 13 April 2026
What this trial tests

Phase 1 trial testing Low Dose MSH2-/- tumor cell vaccine in pMMR/MSS Advanced Colorectal Cancer in 9 participants. Currently enrolling.

Timeline
1 April 2026
Primary endpoint
1 November 2026
1 October 2027

Quick facts

Lead sponsorWest China Hospital
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment9
Start date1 April 2026
Primary completion1 November 2026
Estimated completion1 October 2027
Sites2 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

West China Hospital

Who can join

Adults 18 to 75, any sex, with pMMR/MSS Advanced Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for pMMR/MSS Advanced Colorectal Cancer

Currently open trials in the same condition.

Other West China Hospital trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07510308.

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