About this trial
The primary objective of this study is to evaluate the feasibility, safety, and efficacy of personalized T-cell therapy based on tumor neoantigens in patients with advanced colorectal cancer, so as to provide a novel individualized therapeutic strategy for such patients.
Eligibility criteria
Qualifiers
Aged ≥ 18 years and ≤ 70 years;
Patients with pathologically and radiologically confirmed advanced colorectal cancer, with at least one measurable lesion on imaging;
Failure of standard therapy, ineligibility for standard therapy, or refusal to receive standard therapy;
Expected survival of at least 6 months;
Disqualifiers
Unwilling to sign the informed consent form.
No actionable neoantigens identified for personalized immunotherapy after sequencing data analysis.
History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation.
Concomitant use of any other anticancer drugs, investigational anticancer therapy, or immunosuppressive agents; long-term use of systemic glucocorticoids.
Trial design
Treatments tested in this trial
- iNeo-Vac-T01
Treatment groups
Sponsors and collaborators
Ying Yuan, MD
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor institution
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborator