Tests infusion of immune cells in people with advanced solid tumors
Tests infused iNKT and CD8 T cells in adults with advanced solid cancers.
Key facts
- Who runs it
- Shanghai Public Health Clinical Center
- Where
- Shanghai, ChinaSee the site
- Trial code
- Registry title
- Clinical Safty and Efficacy Study of Infusion of iNKT Cells and CD8+T Cells in Patients With Advanced Solid Tumor
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 40 people, planned
- Started
- 1 Mar 2017
- Expected to end
- 31 Dec 2030
- Type of study
- Interventional
- Treatments tested
- Infusion of iNKT cells and CD8+T cells
- Record updated
- 2 July 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 70 with advanced lung, stomach, pancreas, liver or colorectal cancer. They will get an infusion of iNKT cells and CD8+T cells.
- Age
- 18 Years to 70 Years
- Sex
- All sexes can join.
- Disease stage
- Advanced lung, gastric, pancreas or colorectal cancer, or hepatocellular carcinoma, confirmed by tissue or cell tests. Karnofsky performance status of 80% or more.
- Earlier treatment
- No chemotherapy at the same time. No other trial with an investigational drug within 4 weeks before the first dose.
- Biomarker or test result
- Blood test values must be in set ranges, for example hemoglobin 8.0 g/dL or more and platelet count 50E9/L or more. Oxygen saturation 90% or more on room air.
Main reasons for not taking part
- Serious heart, kidney, lung or liver problems
- Lymphoma, leukemia or myelodysplastic syndrome
- Past immunodeficiency or autoimmune disease
- Positive HIV, hepatitis B or hepatitis C tests
- Pregnant or breast-feeding
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- Histological or cytologically diagnosis of advanced lung cancer, or advanced gastric cancer, or advanced pancrease cancer, or hepatocellular carcinoma, or advanced colorectal cancer
- Patients' tumor tissue (formalin-fixed, paraffin-embedded) must be sufficient for diagnosis of cancer by a certified Laboratory of Pathology
- Laboratory values within the following ranges prior to receiving treatment of study agent: Hemoglobin≧8.0 g/dL, Neutrophils count≧1E9/L, Lymphocytes count≧lower limit of institutional normal, Platelet count≧50E9/L, Serum creatinine≦2.0 mg/dL, Serum bilirubin≦2 x upper limit of institutional normal, AST/ALT≦2 x upper limit of institutional normal
- No dyspnea at rest. Oxygen saturation ≥90% on room air
- No genetic disease
- Fertile females/males must consent to use contraceptives during participation of the trial. Women of child bearing potential must have a negative pregnancy test prior to receiving treatment of study agent within 7 days
- Patients must have a Karnofsky performance status greater than or equal to 80%
- Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure
- Agrees to participate in long-term follow-up for up to 1 years, if received NKT infusion
Who cannot take part
- Positive HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C PCR within 21 days prior to enrollment
- Within concurrent chemotherapy
- Concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent
- Organ dysfunction,such as significant cardiovascular disease, myocardial infarction within the past six months, unstable angina, coronary angioplasty within the past six months, uncontrolled atrial or ventricular cardiac arrhythmias; Child-Pugh C; Renal function failure or uremia; Respiratory failure; Disturbance of consciousness; Renal failure
- Serious infections requiring antibiotics, bleeding disorders
- Patients with myelodysplastic syndrome (MDS)
- History of immunodeficiency disease or autoimmune disease
- Suffering from lymphoma or leukemia
- Pregnant or breast-feeding patients
- Can't give informed consent
- Lack of availability for follow-up assessment
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in China
- Shanghai Public Health Clinical CenterShanghai, ChinaContact: Yan X Zhang, M.D.Taking people
About the trial
What the trial wants to find out
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.
The group in the trial
- treatmentTreatment being tested
The eligible patient receive the experimental infusion of iNKT cells and CD8+T cells .
Treatment: Infusion of iNKT cells and CD8+T cells
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Phace I and II Study of Immunotherapy Strategy Used iNKT Cells and CD8+T Cells in Patients With Advanced Tumor
- Plain-language title
- Tests infusion of immune cells in people with advanced solid tumorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT03093688, who can take part
- Record updated
- 2 July 2025