CART-PSMA Cells for Advanced Prostate Cancer
This is a single center, open-label phase 1 study to assess the safety and feasibility of PSMA-specific CAR modified autologous T cells (CART-PSMA cells) in patients with advanced prostate cancer.
| Condition(s) | Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is a single center, open-label phase 1 study to assess the safety and feasibility of PSMA-specific CAR modified autologous T cells (CART-PSMA cells) in patients with advanced prostate cancer. |
| Who can participate | Inclusion Criteria: 1. All participants must have the ability to understand and the willingness to sign a written informed consent. 2. Histologic confirmation of prostate cancer. 3. Tumor expressing PSMA as demonstrated by immunohistochemistry analysis or other methods. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2. 5. Under general air conditions, blood oxygen saturation \>90%. 6. Adequate liver function, specifically alanine aminotransferase (ALT) \< 3 times of upper limit of normal (ULN), aspartate transferase (AST)\< 3 times of ULN, serum bilirubin and alkaline phosphatase \< 2 times of ULN. 7. Adequate renal function, specifically serum creatinine \< 2.0 mg/dl. 8. Adequate cardiac function, specifically left ventricular ejection fraction (LVEF)≥50%. 9. Hemoglob |
| Ages | 35 Years to 85 Years |
| Sex | Male |
| Lead sponsor | Nova Therapeutics LLC |
| Locations | Beijing, China |
| Start date | 2023-03-01 |
| NCT ID | NCT05656573 |
| Official listing | https://clinicaltrials.gov/study/NCT05656573 |