Actively Recruiting
CXCL Chemokine and TNF Superfamily Co-stimulatory Molecule-modified Mesenchymal Stem Cells for Treatment of Advanced Colorectal Cancer
Led by Shanghai East Hospital · Updated on 2024-06-06
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and efficacy of human umbilical cord-derived mesenchymal stem cells (MSCs) that have been genetically modified to express antitumor chemokines and co-stimulatory molecules in patients with advanced colorectal cancer. These modified MSCs are designed to migrate into solid tumors, attract immune cells like T and natural killer cells, and stimulate these immune cells to enhance antitumor immunity. This early-phase study aims to explore a new immunotherapeutic strategy for tumors that may not respond well to current immune checkpoint treatments. Participants will receive intravenous infusions of these modified MSCs every 21 days for at least six cycles. The doses will be increased stepwise in an initial group to determine the optimal dose for the remaining patients. This treatment approach involves administering between 1 and 3 million cells per kilogram of body weight. The study focuses on a single experimental treatment group receiving this novel cell therapy. During the study, participants will be closely monitored for dose-limiting toxicities and adverse events over four months to assess safety. Researchers will also track disease control rate, progression-free survival, and overall survival over 24 months. Blood samples will be collected 21 days after the first infusion to study how the modified cells behave in the body. The total duration of participation and detailed evaluations will ensure thorough assessment of treatment effects and participant safety.
CONDITIONS
Brief Title
Chemokine and Co-stimulatory Molecule-modified Mesenchymal Stem Cells for the Treatment of Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Diagnosed with metastatic or locally advanced colorectal cancer confirmed by pathology or cytology
- Very few measurable tumor lesions according to RECIST version 1.1
- Have progressed on or are intolerant to standard treatments, or have refused standard treatments
- Adequate blood and organ function including lymphocyte count ≥ 0.8 x 10^9/L, neutrophil count ≥ 1.5 x 10^9/L, hemoglobin ≥ 9 g/dL, platelet count ≥ 75 x 10^9/L; liver enzymes ALT and AST ≤ 3 times upper limit of normal, creatinine ≤ 1.5 times upper limit
- Coagulation parameters (APTT, PT, INR) ≤ 1.5 times upper limit of normal
- ECOG performance status score between 0 and 2
- Agree to use reliable contraception during the study and for at least 12 weeks after last treatment if of reproductive potential
- No adoptive immune cell or stem cell therapy within past two years
- Willing to provide written informed consent
You will not qualify if you...
- History of allergies to biological agents or ingredients used in cell culture
- Pregnant or breastfeeding
- Expected life expectancy less than 3 months
- Active or uncontrolled infections requiring systemic treatment
- Unresolved adverse reactions from previous anti-tumor treatments above CTCAE level 1 (excluding hair loss)
- History of severe cerebrovascular or cardiovascular diseases, including recent acute coronary events, heart failure, or stroke within 6 months
- Poorly controlled hypertension despite treatment
- Severe pulmonary diseases or high risk of venous thromboembolism
- Clinical symptoms or suspicion of central nervous system metastasis or cancerous meningitis (stable brain metastasis allowed)
- Clinically confirmed autoimmune diseases excluding thyroiditis
- HIV infection or acute EBV or CMV infections
- Active hepatitis B or C infection
- Previous allogeneic bone marrow transplantation
- Immunosuppressive conditions or use of systemic steroids or immunosuppressants within 14 days before treatment
- Known alcohol or drug dependence
- Other medical conditions or abnormalities that may hinder full participation based on investigator assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 18 weeks (6 cycles of 21 days each)
Participants receive human umbilical cord-derived mesenchymal stem cells genetically modified to express antitumor chemokine and co-stimulatory molecule. The cells are administered intravenously every 21 days for at least 6 cycles.
At least 6 infusion visits every 21 days
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital (South Division)
Shanghai, Shanghai Municipality, China, 200123
Actively Recruiting
Research Team
Y
Yanan Hai, MD
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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