Tests CART-PSMA cells in adults with advanced prostate cancer
Tests whether modified patient T cells are safe and workable in advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: CART-PSMA Cells for Advanced Prostate Cancer
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 35 and 85 years old?
Source: NCT05656573, who can take part
Where in China
- Chinese PLA General HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nova Therapeutics LLC
- Trial code
- NCT05656573
- Record updated
- 15 November 2024
- Original description
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.Read full original descriptionShow less
Phase I Study of CART-PSMA Cells in Patients With 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.
Inclusion: All participants must have the ability to understand and the willingness to sign a written informed consent; Histologic confirmation of prostate cancer; Tumor expressing PSMA as demonstrated by immunohistochemistry analysis or other methods; Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2; Under general air conditions, blood oxygen saturation >90%; 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; Adequate renal function, specifically serum creatinine < 2.0 mg/dl; Adequate cardiac function, specifically left ventricular ejection fraction (LVEF)≥50%; Hemoglobin concentration ≥80g/L; The side effects brought by the latest treatment should be recovered, and the latest chemotherapy should be at least 7 days before; At least three t½ have passed since the latest immunotherapy.
Exclusion: Patients who are already undergoing other clinical drug trials or other gene therapy or cell therapy; Patients who are being treated with immunosuppressive agents or systemic steroids (other than inhalation therapy); Patients with other malignant tumors or major diseases; Patients with uncontrolled active infection; Patients with active hepatitis B or hepatitis C infection; Patients with human immunodeficiency virus (HIV) infection; Patients with various types of serious heart disease or a history of severe cerebrovascular disease; Patients with congenital immune deficiency diseases or bone marrow deficiency diseases; Patients with active autoimmune disease, including connective tissue disease, uveitis, inflammatory bowel disease, or multiple sclerosis; or a history of severe (as judged by the physician-investigator) autoimmune disease requiring prolonged immunosuppressive therapy; Patients with active medical condition that, in the opinion of the physician-investigator, would substantially increase the risk of uncontrollable CRS (cytokine release syndrome) or CAR Neurotoxicity.