Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06446050

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

Led by Shanghai East Hospital · Updated on 2024-06-06

30

Participants Needed

1

Research Sites

232 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 18 years or older
  • Diagnosed with metastatic or locally advanced colorectal cancer confirmed by pathology or cytology
  • Have very few measurable tumor lesions according to RECIST version 1.1
  • Have progressed on, are intolerant to, or refuse standard treatment
  • Meet blood and organ function requirements: lymphocyte count 20.8 x 10^9/L, absolute neutrophil count 1.5 x 10^9/L, hemoglobin 9 g/dL, platelet count 75 x 10^9/L; ALT and AST 3 times upper limit of normal; creatinine 1.5 times upper limit of normal; APTT, PT, and INR 1.5 times upper limit of normal
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Agree to use reliable contraception during the study and for at least 12 weeks after last treatment if fertile
  • Have not received other adoptive immune cell or stem cell therapies within two years
  • Willing and able to provide written informed consent
Not Eligible

You will not qualify if you...

  • History of allergies to biological agents or any components used in cell culture
  • Pregnant or breastfeeding individuals
  • Life expectancy less than 3 months
  • Active or uncontrolled infections requiring systemic treatment
  • Ongoing severe adverse reactions from prior anti-tumor treatments not recovered to CTCAE level 1 or below (except hair loss)
  • History of severe cerebrovascular disease, recent major cardiovascular events within 6 months, or significant heart function impairment
  • Severe pulmonary or vascular diseases including high risk for venous thromboembolism or requiring oxygen therapy
  • Symptoms or evidence of active central nervous system metastasis or cancerous meningitis
  • Clinically confirmed autoimmune diseases (excluding thyroiditis)
  • HIV infection or active Epstein-Barr virus or cytomegalovirus infection
  • Active hepatitis B or C infection
  • History of allogeneic bone marrow transplantation
  • Immunosuppression including recent use of systemic steroids (>10 mg prednisone daily) or other immunosuppressants
  • Known alcohol or drug dependence
  • Any medical condition or laboratory abnormality that may interfere with full participation or safety as assessed by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Shanghai East Hospital (South Division)

Shanghai, Shanghai Municipality, China, 200123

Actively Recruiting

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Research Team

Y

Yanan Hai, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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