Personalized T-Cell Therapy iNeo-Vac-T01 in Advanced Colorectal Cancer

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorYing Yuan, MD

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

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Ying Yuan, MD

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor institution

Hangzhou Neoantigen Therapeutics Co., Ltd.

Collaborator