NCT03093688 Clinical Safty and Efficacy Study of Infusion of iNKT Cells and CD8+T Cells in Patients With Advanced Solid Tumor
| NCT ID | NCT03093688 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shanghai Public Health Clinical Center |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2017-03-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2017-03-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * Suffering from lymphoma or leukemia * Serious infections requiring antibiotics, bleeding disorders * Patients with myelodysplastic syndrome (MDS) * History of immunodeficiency disease or autoimmune disease * 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 * Pregnant or breast-feeding patients * Can't give informed consent * Lack of availability for follow-up assessment
Contact & Investigator
Qing J Xu, M.D. Ph.D
STUDY CHAIR
Shanghai Public Health Clinical Center
Frequently Asked Questions
Who can join the NCT03093688 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03093688 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03093688 currently recruiting?
Yes, NCT03093688 is actively recruiting participants. Contact the research team at zhangxiaoyan@shaphc.org for enrollment information.
Where is the NCT03093688 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT03093688 clinical trial?
NCT03093688 is sponsored by Shanghai Public Health Clinical Center. The principal investigator is Qing J Xu, M.D. Ph.D at Shanghai Public Health Clinical Center. The trial plans to enroll 40 participants.
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