Solid tumor
Conditions
Interventions
Immunization Program A:Subjects were given one single injection of this productafter the start of treatment. The first three injections were given one week apart to activate the anti-tumor immune resp
Immunization Program B:Subjects were given one single injection of this product after the start of treatment. The first three injections were given one week apart to activate the anti-tumor immune res
Sponsors
Chinese People's Liberation Army General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The age of the subject should be between 18 and 75 years old (including the boundary value), regardless of gender; 2.Subjects with advanced or metastatic malignancies confirmed by histopathology or cytology, failure of standard treatment or no standard treatment options, or intolerance to standard treatment. 3.A physical status of 0 or 1 on the Eastern Cancer Collaboration (ECOG) score; 4. Subjects must have at least one measurable target lesion according to RECIST1.1 criteria [Patients with liver cancer, according to RECIST1.1, while referring to Mrecist, have at least one measurable lesion. Lesions located in areas previously treated with radiation or with clear progression (based on RECIST1.1 and referring to Mrecist criteria) after local treatment are considered measurable lesions]; 5. Laboratory test values meet the following conditions: Sufficient hematology and end-organ function as defined by the following laboratory test results, which must be completed within 7 days prior to the first investigational treatment: Blood routine: platelets (PLT) >=90×10^9/L, neutrophil (ANC) >=1.5×10^9/L, hemoglobin (HGB) >=90 g/L; Liver function: serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3 g/Dl; Renal function: creatinine clearance rate (CrCl) >=45mL/minute (creatinine clearance can be calculated using the Cockcroft-Gault formula, the Chronic Kidney Disease Epidemiology Collaborative Study formula, or the Kidney Disease Diet Modification formula). Urine protein =2+, additional 24-hour urine protein measurement is required. Subjects with 24-hour urine protein measurement 1.5 x ULN without clinical or imaging evidence of pancreatitis can be included in the group); Amylase 1.5 ×ULN has no clinical or imaging evidence of pancreatitis, it can be included in the group); alkaline phosphatase (ALP) =50%; 11. Adequate venous access for peripheral blood mononuclear cells (
Exclusion criteria
Exclusion criteria: 1.Pathological examination indicated malignant tumor with T cell origin; 2.Central nervous system (CNS) metastases with central nervous system symptoms, untreated or progressive; 3. Patients diagnosed with liver cancer: complicated with hepatic encephalopathy; Or have a bleeding event of esophageal or fundus varices caused by portal hypertension within the past 6 months; Or the presence of known severe (G3) varicose veins on endoscopy within 3 months prior to initial dosing; 4. Participants who have participated in clinical trials of other drugs within 4 weeks before the first treatment, or who have received other anti-tumor therapy after screening; Peripheral blood mononuclear cells received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte macrophage colony-stimulating factor (GM-CSF) treatment within 14 days before harvest. Live virus vaccination within 28 days before the first treatment; 5. Have any active autoimmune disease (interstitial pneumonia, uveitis, enteritis, pituitaritis, vasculitis, myocarditis, nephritis, hyperthyroidism, psoriasis and rheumatoid arthritis); Or long-term use of immunosuppressive therapy drugs for organ transplantation or other reasons; Or a known allergy to eggs; 6. Positive human immunodeficiency virus antibodies (HIV-Ab) or anti-treponema pallidum antibodies (TP-Ab), active hepatitis such as active hepatitis B (HBV-DNA=2000 copy number /mL) or hepatitis C (HCV antibody positive and HCV-RNA higher than the lower detection limit of analytical methods); 7. Patients who have received systemic immunosuppressive therapy (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide and anti-tumor necrosis factor [anti-TNF] drugs, etc.) within 30 days before the first treatment; Patients receiving short-term, systemic immunosuppressant therapy (such as glucocorticoids for nausea, vomiting, or anaphylaxis management or prophylaxis) may be enrolled in this study after investigator consultation with sponsor and sponsor approval. In these patients, it will also be determined with the sponsor whether a washout period is required prior to the first treatment and the duration of the washout period; To allow the use of inhaled corticosteroids in patients with chronic obstructive pulmonary disease, corticosteroids (such as hydrocortisone) for postural hypotension, and low-dose corticosteroids (<=10 mg/ day of prednisone or equivalent) supplements for adrenal cortical dysfunction; 8. Prior history of severe vaccine allergy, or use of live attenuated vaccine within 28 days before the first treatment, or expected use of live attenuated vaccine during the study period (patients are not allowed to receive live attenuated influenza vaccine within 28 days before the first treatment, during treatment, and within 6 months after the last administration of the investigatory drug); 9. Systemic diseases not controlled by treatment. For example, after treatment of uncontrolled cardiovascular disease [NYHA standard Class III-IV chronic heart failure, unstable angina, or myocardial infarction within 6 months, etc.], organ failure (renal failure and uremia stage; Respiratory failure), diabetes mellitus, grade 3 and poorly controlled hypertension; 10. Subjects who have a history of uncontrolled psychosis, or who, as assessed by the investigator, have a history of existing medical or psychiatric conditions that could increase the risk associat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the incidence of adverse events (AEs) and serious adverse events (SAEs);;DLT(Dose-limiting toxicity); | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR (Objective Response Rate);DCR (Disease Control Rate);BOR(Best of response);CBR (Clinical Benefit Rate);PFS (Progression Free Survival);OS (Overall survival); | — |
Countries
China
Contacts
Public ContactJianming Xu
Chinese PLA Genera Hosptial
Outcome results
None listed