Chemokine and Co-stimulatory Molecule-modified Mesenchymal Stem Cells for the Treatment of Advanced Colorectal Cancer
- Conditions
- Advanced Colorectal Cancer
- Interventions
- Biological: MSC-L
- Registration Number
- NCT06446050
- Lead Sponsor
- Shanghai East Hospital
- Brief 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), 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MSC-L MSC-L Mesenchymal Stem Cells mobilizing Lymphocytes (MSC-L)
- Primary Outcome Measures
Name Time Method Dose-Limiting Toxicities rate (DLT) 4 months Proportion of patients who has experienced a DLT
Adverse Event (AE) 4 months Proportion of patients who has experienced an AE
Determination of optimal dose of MSC-L 4 months The largest dose that has an estimated risk of causing DLT (defined as MSC-L related adverse event of grade 3 or higher) equal or closest to the target level of 35% (the target toxicity level).
- Secondary Outcome Measures
Name Time Method MSC-L kinetics in peripheral blood 21 days post first infusion Quantification of circulating MSC-L in the blood.
Disease Control Rate (DCR) 24 months Percentage of patients cancer whose MSC-L treatment has led to a complete response, partial response, or stable disease.
Overall Survival (OS) 24 months Time from the date of first dose of study treatment to the date of death.
Progression-free survival (PFS) 24 months Time from the date of first dose of study treatment to the date of progression or death from any cause.
Trial Locations
- Locations (1)
Shanghai East Hospital (South Division)
🇨🇳Shanghai, Shanghai, China