Actively Recruiting
Clinical Safty and Efficacy Study of Infusion of iNKT Cells and CD8+T Cells in Patients With Advanced Solid Tumor
Led by Shanghai Public Health Clinical Center · Updated on 2025-07-02
40
Participants Needed
1
Research Sites
721 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells. PD-1+CD8+T cells of patients with advanced tumor are most likely tumor-specified. Our hypothesis is that immunotherapy strategy of infusion of iNKT cells and PD-1+CD8+T cells may decrease the tumor burden and improve overall survival. The purpose of this study is to assess the safety and efficacy of treatment of patients with advanced solid tumor by infusing of iNKT cells and PD-1+CD8+T cells.
CONDITIONS
Official Title
Clinical Safty and Efficacy Study of Infusion of iNKT Cells and CD8+T Cells in Patients With Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological diagnosis of advanced lung, gastric, pancreas, liver, or colorectal cancer
- Tumor tissue must be sufficient for diagnosis by a certified pathology laboratory
- Hemoglobin at least 8.0 g/dL
- Neutrophil count at least 1 x 10^9/L
- Lymphocyte count at or above institutional lower limit
- Platelet count at least 50 x 10^9/L
- Serum creatinine 2.0 mg/dL or less
- Serum bilirubin no more than twice the upper institutional limit
- AST/ALT no more than twice the upper institutional limit
- No dyspnea at rest with oxygen saturation at least 90% on room air
- No genetic diseases
- Fertile females and males must agree to use contraception during the study
- Women of childbearing potential must have a negative pregnancy test within 7 days before treatment
- Karnofsky performance status of 80% or higher
- Able and willing to give written informed consent
- Agree to participate in long-term follow-up for up to 1 year if infused with NKT cells
You will not qualify if you...
- Significant organ dysfunction such as recent heart attack, unstable angina, or serious arrhythmias
- Child-Pugh C liver disease
- Renal failure or uremia
- Respiratory failure or disturbed consciousness
- History of lymphoma or leukemia
- Serious infections requiring antibiotics or bleeding disorders
- Myelodysplastic syndrome (MDS)
- History of immunodeficiency or autoimmune disease
- Positive for HIV, Hepatitis B surface antigen, or Hepatitis C PCR within 21 days before enrollment
- Receiving concurrent chemotherapy
- Other medical conditions preventing protocol-based therapy
- Participation in another clinical trial with an investigational agent within 4 weeks prior
- Pregnant or breastfeeding
- Unable to give informed consent
- Unavailable for follow-up assessments
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China, 201508
Actively Recruiting
Research Team
Y
Yan X Zhang, M.D.
CONTACT
R
Recruiting
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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