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NCT07510308
Clinical Study of MSH2-/- Tumor Cell Vaccines for Advanced pMMR Colorectal Cancer Patients
Phase 1 trial testing Low Dose MSH2-/- tumor cell vaccine in pMMR/MSS Advanced Colorectal Cancer in 9 participants. Currently enrolling.
1 November 2026
Quick facts
| Lead sponsor | West China Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 1 April 2026 |
| Primary completion | 1 November 2026 |
| Estimated completion | 1 October 2027 |
| Sites | 2 locations across China |
Drugs / interventions tested
- Low Dose MSH2-/- tumor cell vaccine
- Medium Dose MSH2-/- tumor cell vaccine
- High dose MSH2-/- tumor cell vaccine
Conditions studied
- pMMR/MSS Advanced Colorectal Cancer — all drugs for pMMR/MSS Advanced Colorectal Cancer →
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.
Verify or expand the search:
- PubMed search for NCT07510308
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Related trials
Other recruiting trials for pMMR/MSS Advanced Colorectal Cancer
Currently open trials in the same condition.
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Other West China Hospital trials
Trials by the same sponsor.
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- NCT07583654 — Safety, Tolerability, and Preliminary Antitumor Activity of Cationic Peptide-IL22BP mRNA in Advanced Solid Tumors · Phase 1 · not yet recruiting
- NCT07492914 — Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma · Phase 2 · recruiting
- NCT07507097 — Study on the Optimal Head Position for Patients With Severe Acute Ischemic Stroke · NA · not yet recruiting
- NCT07457281 — GV20-0251 and Sintilimab for Neoadjuvant Treatment of Resectable Head and Neck Squamous Cell Carcinoma: A Single-Arm Stu · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07510308 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by West China Hospital
- Last refreshed: 13 April 2026
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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