NCT03093688RecruitingPhase 1/2
Clinical Safty and Efficacy Study of Infusion of iNKT Cells and CD8+T Cells in Patients With Advanced Solid Tumor
Phace I and II Study of Immunotherapy Strategy Used iNKT Cells and CD8+T Cells in Patients With Advanced Tumor
Source: ClinicalTrials.gov · Last updated 2 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 15 Mar 2017
- Start date
- 1 Mar 2017
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Shanghai Public Health Clinical Center
- Diseases
- Kidney cancer, Lung cancer, Pancreatic cancer, Liver and biliary tract cancer, Gastric and esophageal cancer
- NCT number
- NCT03093688
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 40
- From 1 Mar 2017 to the primary completion date, 31 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Suffering from lymphoma or leukemia
- Pregnant or breast-feeding patients
- Can't give informed consent
- Lack of availability for follow-up assessment
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Public Health Clinical Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.