CART-PSMA Cells for Advanced Prostate Cancer

Launched by NOVA THERAPEUTICS LLC · Dec 12, 2022

Keywords

ClinConnect Summary

The CART-PSMA trial is studying a new treatment for men with advanced prostate cancer. This treatment involves modifying a type of immune cell called T cells to better target and attack prostate cancer cells that express a protein known as PSMA. The goal of this study is to see if this new approach is safe and if it can be effectively used in patients. Right now, the trial is actively looking for eligible participants.

To join the trial, men must have a confirmed diagnosis of prostate cancer that shows PSMA, be in generally good health, and have recovered from any recent treatments. Participants should be able to understand the trial and sign a consent form. Throughout the study, participants will receive close monitoring to ensure their safety. It’s important to note that some individuals with other serious health conditions or those currently receiving other treatments may not qualify for this trial. Overall, this study offers a potential new option for men with advanced prostate cancer who are looking for innovative therapies.

Gender

MALE

Eligibility criteria

• 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. Hemoglobin concentration ≥80g/L.
• • 10. 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 Criteria:
• • 1. Patients with other malignant tumors or major diseases.
• • 2. Patients who are already undergoing other clinical drug trials or other gene therapy or cell therapy.
• • 3. Patients with uncontrolled active infection.
• • 4. Patients with active hepatitis B or hepatitis C infection.
• • 5. Patients with human immunodeficiency virus (HIV) infection.
• • 6. Patients who are being treated with immunosuppressive agents or systemic steroids (other than inhalation therapy).
• • 7. Patients with various types of serious heart disease or a history of severe cerebrovascular disease.
• • 8. Patients with congenital immune deficiency diseases or bone marrow deficiency diseases.
• • 9. 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.
• • 10. 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.