Chemokine and Co-stimulatory Molecule-modified Mesenchymal Stem Cells for the Treatment of Advanced Colorectal Cancer
Recruiting now · Early Phase 1
Conditions studied: Advanced Colorectal Cancer
In brief
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.
Key facts
- Study ID
- NCT06446050
- Run by
- Shanghai East Hospital
- People needed
- 30
- Starts
- 2023-06-21
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2024-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Shanghai East Hospital (South Division) — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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