Pleural Effusion, Malignant Clinical Trial
Official title:
Phase I Study of Specific CAR-T Dual-targeting HER2 and PD-L1 in Patients With Pleural or Peritoneal Metastasis of HER2 Positive Cancer
Verified date | November 2023 |
Source | Sichuan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Serosal cavity metastasis of malignant tumor is one of the late complications, which seriously affects the quality of life and survival time of patients. HER-2 is frequently expressed in breast cancer, ovarian cancer, lung cancer, gastric cancer and other malignant tumors. The HER-2/PD-L1 dual-targeting CAR-T will be investigated in patients with HER2 positive solid tumor serosal cavity metastases.
Status | Recruiting |
Enrollment | 18 |
Est. completion date | December 30, 2025 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Male or female, Age 18-65 years old; 2. Estimated life expectancy = 3 months (according to investigator's judgement); 3. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2; 4. Patients diagnosed as ovarian cancer, non-small cell lung cancer, breast cancer, gastric cancer, etc., accompanied by serous cavity metastasis, have received systemic standard treatment, and have clinical symptoms of serous cavity metastasis; 5. Expressing HER2 >20% of primary tumors or metastatic cells in the serous cavity by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH); 6. Absolute neutrophil count = 1×10^9/L, platelet count = 75×10^9/L, absolute lymphocyte count =1×10^8/L, hemoglobin = 9.0 g/dl; 7. Creatinine clearance rate =60ml/min, Serum ALT/AST=2.5 times of the normal level, and total bilirubin=1.5 times of the normal level; 8. Cardiac ejection fraction =50%, no pericardial effusion; 9. No other serious diseases (autoimmune diseases or any immune deficiency disease or other disease in need of immunosuppressive therapy); 10. Patients must stop chemotherapy and targeted therapy for at least 3 weeks before starting treatment; 11. Patients must take reliable contraceptive measures before entering the trial, during the research process until 1 year after CAR-T infusion; reliable contraceptive measures will be determined by the main investigator or designated personnel; 12. Voluntarily participate in the research, understand and sign the informed consent; 13. The side effect of the last anti-tumor treatment was reduced to =1 grade, except for hair loss. Exclusion Criteria: 1. Allergic to cytokines; 2. Uncontrolled activity infection; 3. Acute or chronic (graft-versus-host disease) GVHD; 4. Accompanied by other uncontrolled malignant tumors; 5. Patient with hepatitis B or C active period, HIV infection = the upper limit of the normal level; 6. Suffer from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, etc.; 7. Patients with grade 2-3 hypertension or poorly controlled; 8. History of mental illness that is difficult to control; 9. Patients have used immunosuppressive agents for a long time after organ transplantation, except for recent or current inhaled corticosteroid therapy; 10. The existing medical history or mental state history or laboratory abnormalities may increase the risk associated with participating in the study or the administration of the study drug; 11. Unstable pulmonary embolism, deep venous embolism or other major arterial/venous thromboembolic events occurred within 6 months before enrollment. If receiving anticoagulant therapy; 12. Pregnant or nursing women, or plan to become pregnant during the treatment period or within 1 year after the treatment ends; 13. Patient suffering from diseases that have signed written informed consent or comply with research procedures; or are unwilling or unable to comply with research requirements. |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital, Sichuan University | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Sichuan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Related Adverse Events | AE during the first 28 days after CAR-T cell administration | 12 months | |
Primary | Dose-limiting toxicity (DLT) | Baseline up to 28 days after CAR-T cells infusion | 12 months | |
Secondary | ORR(objective response rate) | Include CR(complete response)and PR(partial response) | Month 1,month 3, month 6 | |
Secondary | DOR (duration of response) | The time from achievement of disease control | 12 months |
Status | Clinical Trial | Phase | |
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