CART-PSMA Cells for Advanced Prostate Cancer
Recruiting now · Phase 1
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT05656573
- Run by
- Nova Therapeutics LLC
- People needed
- 20
- Starts
- 2023-03-01
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2024-11-15
Who can join
Age: 35 and older, up to 85. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Patients with other malignant tumors or major diseases.
- Patients who are already undergoing other clinical drug trials or other gene therapy or cell therapy.
- Patients with uncontrolled active infection.
- Patients with active hepatitis B or hepatitis C infection.
- Patients with human immunodeficiency virus (HIV) infection.
- Patients who are being treated with immunosuppressive agents or systemic steroids (other than inhalation therapy).
- 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.
Where it is running
- Chinese PLA General Hospital — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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