The aim of this study is to assess the safety and efficacy of human umbilical cord-derived allogenic mesenchymal stem cells (MSCs) engineered to express antitumor chemokine and co-stimulatory molecule. Following systemic administration, these cells are able to migrate into solid tumors such as colorectal tumors. Once enriched in the tumor, they will attract peripheral lymphocytes consisting of T and natural killer (NK) cells, and simultaneously stimulate the infiltrated lymphocytes for persistent and enhanced antitumor immunity. Thus, this MSC-based treatment provides a potentially effective and targeted immunotherapeutic strategy for tumors with unfavorable immune microenvironment and possibly poor response to immune checkpoint blockade (ICB).
During this investigator-initiated trial (IIT), colorectal cancer patients will receive modified MSCs every 21 days via intravenous infusion. Increasing does will be tested in the initial cohort and an optimal dose will be chosen for the remaining patients.
Age less than 18 years old (including 18 years old), regardless of gender;
Patients with metastatic or locally advanced colorectal cancer confirmed by pathological histology or cytology;
According to the Efficacy Evaluation Criteria for Solid Tumors (RECIST) version 1.1, there are very few measurable tumor lesions;
Individuals who have progressed or are intolerant to standard treatment in the past, or patients who refuse standard treatment;
Individuals with a history of allergies to biological agents or allergies to any ingredients used for cell culture;
Pregnant or lactating individuals;
Expected shelf life of more than 3 months;
Active infections that require systemic treatment or uncontrollable infections;