Actively Recruiting
Clinical Study of MSH2-/- Tumor Cell Vaccines for Advanced pMMR Colorectal Cancer Patients
Led by West China Hospital · Updated on 2026-04-13
9
Participants Needed
2
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Study of MSH2-/- Tumor Cell Vaccines for Advanced pMMR Colorectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years at consent
- Histologically or cytologically confirmed pMMR colorectal cancer
- Failed, intolerant of, or declined standard therapy
- For RAS/BRAF wild-type eligible patients, prior anti-EGFR or anti-VEGF therapy with disease progression
- For BRAF V600E mutation, prior treatment failure with BRAF inhibitor plus chemotherapy
- For others, failure of at least two prior systemic chemotherapies including platinum agents
- At least one measurable or evaluable lesion per RECIST v1.1
- ECOG performance status 0 to 2
- Predicted survival of at least 3 months
- Adequate organ function within 7 days before treatment (blood counts, liver and kidney tests, coagulation, cardiac function)
- Men and women of childbearing potential agree to use effective contraception during and 6 months after vaccination
- Women must have a negative pregnancy test and agree not to breastfeed during the study and for 18 months after vaccination
- At least 4 weeks since last anti-tumor therapy; appropriate washout periods for targeted drugs, radiotherapy, and surgery
You will not qualify if you...
- History of other tumors within past 5 years except certain cured skin and mucosal cancers
- Uncontrolled clinical diseases or major medical conditions interfering with consent or study
- Active autoimmune disease or history of autoimmune disease; asthma requiring bronchodilators
- Allergy to study vaccine or components; history of severe allergic reactions
- Contraindications to subcutaneous injection
- Prior antitumor therapeutic vaccine or cellular immunotherapy
- Participation in other drug or device trials within 4 weeks
- Use of systemic corticosteroids >10 mg prednisone or immunosuppressants within 14 days before first dose
- Unresolved toxic effects from previous cancer therapy worse than grade 1 except alopecia or grade 2 neuropathy
- Active infections including tuberculosis, hepatitis B or C, or HIV
- History of substance abuse or significant medical, psychological, or social conditions
- Vaccination with any vaccine within 30 days before study vaccine or planned vaccination during study
- Any other condition judged by investigator to interfere with study or safety
- Inability or unwillingness to comply with study requirements
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Trial Site Locations
Total: 2 locations
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
2
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
X
Xingchen Peng, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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