NCT05354375 Clinical Study of PSMA-targeted CAR-T Cells in the Treatment of Castration-resistant Prostate Cancer
| NCT ID | NCT05354375 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | The Affiliated Hospital of Xuzhou Medical University |
| Condition | Immunotherapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2025-11-30 |
Trial Parameters
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Brief Summary
This is an experimental study to evaluate the safety and effectiveness of PSMA-targeted CAR-T cells in the treatment of castration-resistant prostate cancer.
Eligibility Criteria
Inclusion Criteria: 1. Male patients aged from 18 to 75 years old; 2. The patients' ECOG score ≤ 2; 3. Prostate cancer patients in castration resistance stage (with or without distant metastasis): 1. Previous new endocrine therapy is ineffective; 2. Past treatment with too much citabine or cabatase is ineffective. 4. Have measurable or evaluable lesions; 5. The patients' main tissues and organs function well: 1. Liver function: ALT/AST \< 3 times the upper limit of normal value (ULN); 2. renal function: creatinine \< 220 μ mol/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 the informed consent form. Exclusion Criteria: 1. Infectious diseases (such as HIV, active hepatitis B or C infection, active tuberculosis, etc.); 2. Feasibility evaluation screening proves that the transfection of targeted lymphocytes is less than 10% or the amplification und