NCT06446050

Chemokine and Co-stimulatory Molecule-modified Mesenchymal Stem Cells for the Treatment of Advanced Colorectal Cancer

CXCL Chemokine and TNF Superfamily Co-stimulatory Molecule-modified Mesenchymal Stem Cells for the Treatment of Advanced Colorectal Cancer

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	MSC-L	Human umbilical cord-derived mesenchymal stem cells (MSCs) genetically modified to express antitumor chemokine and co-stimulatory molecule will be administered intravenously at a dose of 1/2/3 x 10\^6 cells/kg, every 21 days for at least 6 cycles of treatment.

Timeline

• Start date: 2023-06-21
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-06-06
• Last updated: 2024-06-06

Locations

1 site across 1 country: China