Advanced solid tumor
Conditions
Interventions
Sponsors
Shandong University Qilu Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Between 18 and 65 years old; 2. The immunohistochemistry (IHC) assay of the laboratory recognized by the research cooperation unit is positive for the expression of the target; 3. Cytology or pathology confirmed that it is a solid tumor in the indications of this test plan; 4. Patients who have failed or relapsed after standard treatment; 5. At least one extracranial measurable lesion according to RECIST1.1 standard; 6. Expected survival period >= 90 days; 7. The main organ function is normal, that is, the following criteria are met: (1) ECOG physical status score is 0-1 or KPS score > 70; (2) Blood routine examination standards meet: HB >= 90 g/L (no blood transfusion within 14 days), ANC >= 1.5 x 10^9/L, PLT >= 80 x 10^9/L, Alb >= 2.8 g/dL, serum lipase and amylase 50 ml/min (Cockcroft-Gault formula); (4) Cardiac ejection fraction > 55%; (5) The levels of calcium, potassium and magnesium in serum are within the standard range; 8. No bleeding disorder or coagulation disorder; 9. No allergy to developer; 10. Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate methods of contraception during the experiment and 8 weeks after the last administration of CART (have undergone sterilization or menopause after at least 2 years, women can be considered as infertile); 11. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Previous history of other malignant tumors; 2. The transduction efficiency of T cells is less than 5% or the expansion of T cells after culture is less than 2 times; 3. Participated in other drug clinical trials within 4 weeks before the start of the study; 4. People with hypertension who cannot be well controlled by a single antihypertensive drug (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg, the specific situation is judged by the investigator), suffering from grade I or above myocardial ischemia or myocardial infarction, grade I Arrhythmia and above (including QT interval >= 440 ms) or cardiac insufficiency; 5. Long-term unhealed chest or other wounds or fractures; 6. Those who have a history of psychotropic drug abuse and cannot quit or have a history of mental disorders; 7. Patients with past and current objective evidence of pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function; 8. There are fungal, bacterial, viral or other infections that are uncontrollable or require antibiotic treatment. Uncomplicated urinary tract infection and uncomplicated bacterial pharyngitis are allowed after consultation with the medical monitor; 9. For subjects who have used chemotherapy in the past, according to the NCI-CTCAE4.0 standard, there is >= grade 2 hematological toxicity, or >= grade 3 non-hematological toxicity; 10. Known history of HIV, or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) nucleic acid test positive; 11. Presence of any indwelling catheters or drains (eg, biliary drains or pleural/peritoneal/pericardial catheters). The use of dedicated central venous catheters is allowed (fistulas, percutaneous nephrostomy tubes, and indwelling Foley catheters in patients with bowel cancer, the researchers will consider whether there is any impact); 12. Patients with brain metastases; 13. There is a CNS medical history or disease, such as seizure disorder, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the CNS; 14. There is a major immune deficiency; 15. Have a history of severe hypersensitivity to the main therapeutic drugs in this study (including fludarabine, cyclophosphamide, mesna used during pretreatment, tocilizumab and anti-infective drugs for the prevention and treatment of CRS); 16. History of deep vein thrombosis or pulmonary embolism within 6 months before enrollment; 17. History of autoimmune diseases (eg, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that lead to end organ damage or require systemic immunosuppressive/systemic disease-modifying drugs in the past 2 years; 18. Any disease that may interfere with the safety or efficacy evaluation of the study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (Complete Response [CR] + Partial Response [PR]) of CART Targeted Therapy in Patients with Advanced Solid Tumors;Safety of CART targeted therapy in patients with advanced solid tumors; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of overall response;Progression-free survival; | — |
Countries
China
Contacts
Public ContactLiu Lian
Innovative Cellular Therapeutics Co.,Ltd.
Outcome results
None listed