Chemokine and Co-stimulatory Molecule-modified Mesenchymal Stem Cells for the Treatment of
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 e
| Condition(s) | Advanced Colorectal Cancer |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria (Participants must meet all of the following selection criteria in order to participate in this study): 1. Age less than 18 years old (including 18 years old), regardless of gender; 2. Patients with metastatic or locally advanced colorectal cancer confirmed by pathological histology or cytology; 3. According to the Efficacy Evaluation Criteria for Solid Tumors (RECIST) version 1.1, there are very few measurable tumor lesions; 4. Individuals who have progressed or are intolerant to standard treatment in the past, or patients who refuse standard treatment; 5. Severe abnormalities in the fluid system, liver and kidney function: lymphocyte count ≥ 0.8 × 10\^9/L, absolute neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 9g/dL, platelet count ≥ 75 × 10\^9/L; Alanine aminotransfe |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Shanghai East Hospital |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2023-06-21 |
| NCT ID | NCT06446050 |
| Official listing | https://clinicaltrials.gov/study/NCT06446050 |