Advanced solid tumor
Conditions
Interventions
Low dose:Low dose iNKT cells
Medium dose:Medium dose iNKT cells
High dose:High dose iNKT cells
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with advanced lung cancer, gastric cancer, pancreatic cancer, hepatocellular carcinoma or colorectal cancer confirmed by Clinicopathology; 2. The tumor tissue samples (formalin fixed, paraffin embedded) of patients must be sufficient and uniformly accepted by the central laboratory or fixed Laboratory for diagnosis, histological classification, tumor marker detection, etc; 3. Laboratory values before treatment with the study drug in the following ranges: hemoglobin >= 8.0 g / dl, neutrophil count >= 1e9 / L, lymphocyte count >= lower limit of normal value, platelet count >= 50e9 / L, serum creatinine = 90%; 5. Patients without obvious hereditary diseases; 6. Fertile women / men must agree to use contraceptives during the trial. Women with fertility potential must have a negative pregnancy test within 7 days before receiving the study drug treatment; 7. Patients with ECoG score <= 2; 8. Patients who are able and willing to sign the certified written informed consent to participate in the trial; 9. Patients who agreed to participate in a long-term follow-up of up to 1 year if they received NKT infusion.
Exclusion criteria
Exclusion criteria: 1. Patients with T-cell tumor, such as T-cell lymphoma or NKT cell leukemia; or the tumor has central nervous system metastasis, unless it has been treated and stable; 2. Patients with previous history of other malignant tumors. Patients with skin basal or squamous cell carcinoma and cervical carcinoma in situ who had been cured at any time before the study were excluded; 3. Patients with MDS (myelodysplastic syndrome); or with immune deficiency or autoimmune diseases other than vitiligo; 4. Patients who have received bone marrow, stem cell or organ transplantation; 5. Patients who used immunosuppressive drugs or hormones within one week before enrollment; 6. Patients with active infection: HIV positive, tuberculosis, etc; 7. Patients who have participated in any other clinical trials concerning other research preparations; 8. Patients with severe protein allergy or autoimmune diseases; 9. Patients with severe liver and kidney dysfunction; 10. Pregnant or lactating women, or the patient does not agree to use effective contraceptive measures during the treatment period and the following 1 year; 11. Patients with mental or addictive diseases that may affect their ability to sign informed consent forms; 12. The immune status of patients and clinical follow-up evaluation could not be obtained, and the researchers considered that there were other factors that were not suitable for selection or affected the participation and completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Efficacy (quality of life, time of disease progression, tumor markers, tumor volume); | — |
Countries
China
Contacts
Public ContactXiaoyan Zhang
Shanghai Public Health Clinical Center
Outcome results
None listed