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

NCT06446050 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-06-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai East Hospital

    lead OTHER

Principal Investigators

  • Yong Gao, MD · Shanghai East Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-21
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06446050 on ClinicalTrials.gov