Infusing iNKT and PD-1+ CD8+ T cells for advanced solid tumors
Phace I and II Study of Immunotherapy Strategy Used iNKT Cells and CD8+T Cells in Patients With Advanced Tumor
PHASE1; PHASE2 · Shanghai Public Health Clinical Center · NCT03093688
This study will try giving people with advanced lung, pancreatic, liver, stomach, or colon cancers infusions of iNKT cells and PD-1+ CD8+ T cells to see if tumors shrink and survival improves.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai Public Health Clinical Center (other gov) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT03093688 on ClinicalTrials.gov |
What this trial studies
This phase 1/2 interventional trial gives patients laboratory‑expanded invariant natural killer T (iNKT) cells together with PD‑1+ CD8+ T cells that are likely tumor‑specific. The two cell types are expanded ex vivo from patient samples using the investigators' published/patented methods and then infused back into participants, with close monitoring for safety, immune response, and tumor change. Eligible patients have advanced solid tumors (including lung, pancreas, liver, stomach, and colorectal cancers) and undergo regular laboratory testing and imaging during follow‑up. Primary endpoints focus on safety and tolerability, with secondary measures including changes in tumor burden and overall survival.
Who should consider this trial
Good fit: Adults with histologically confirmed advanced (metastatic or unresectable) non‑small cell or small cell lung cancer, pancreatic cancer, hepatocellular carcinoma, gastric cancer, or colorectal cancer who meet laboratory and organ‑function criteria and can attend the study site are ideal candidates.
Not a fit: Patients with early‑stage disease, poor organ function, active uncontrolled infections, significant comorbidities, genetic diseases, pregnancy, or inability to undergo leukapheresis or travel to Shanghai are unlikely to receive benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce tumor burden and potentially extend survival for people with advanced solid tumors.
How similar studies have performed: Preclinical mouse studies reported safety for iNKT and CD8+ T cell infusions and other early‑phase cellular immunotherapies have shown responses in some cancers, but the specific combination of iNKT plus PD‑1+ CD8+ T cells is novel with limited clinical data to date.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Public Health Clinical Center — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Yan X Zhang, M.D.
- Email: zhangxiaoyan@shaphc.org
- Phone: 0086-021-37990333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-small Cell Lung Cancer, Small Cell Lung Cancer, Pancreas Cancer, Hepatocellular Carcinoma, Gastric Cancer, Renal Cell Carcinoma