NCT04969354 Clinical Study of CAIX-targeted CAR-T Cells in the Treatment of Advanced Renal Cell Carcinoma
| NCT ID | NCT04969354 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | The Affiliated Hospital of Xuzhou Medical University |
| Condition | Immunotherapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-10-01 |
| Primary Completion | 2025-09-30 |
Trial Parameters
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Brief Summary
This is an experimental study to evaluate the safety and efficacy of CAR T cells targeting CAIX in the treatment of advanced renal cancer.
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients aged from 18 to 70 years old; 2. The patient's ECOG score is ≤ 2; 3. Patients with advanced or metastatic renal cell carcinoma: (1) have received first-line and second-line targeted therapy in the past; (2) Previous immunization with PD-1/L1 and ≤2 regimens; (3) Unable to tolerate targeted therapy or immunotherapy. 4.There are measurable or evaluable lesions; 5.The main tissues and organs of patients function well: 1. liver function: ALT/AST\< 3 times the upper limit of normal value (ULN); 2. Renal function: creatinine \< 220 μmol/L; 3. Lung function: indoor oxygen saturation ≥ 95%; 4. Cardiac function: Left ventricular ejection fraction (LVEF)≥40% 6.Patients or their legal guardians voluntarily participate and sign informed consent. Exclusion Criteria: 1. Infectious diseases (such as HIV, active hepatitis B or C infection, active tuberculosis, etc.); 2. Feasibility assessment and screening showed that the transfection of targeted lymphocy