Using modified T cells to treat advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 clinical trial evaluates the safety and feasibility of PSMA-specific CAR modified autologous T cells, known as CART-PSMA cells, in patients with advanced prostate cancer. The study is divided into two parts: a dose escalation phase and an expansion cohort, with a total enrollment of up to 20 patients. Participants will receive CART-PSMA cells to determine the treatment's effects and tolerability.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chinese PLA General Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Jay Zhang, MD/PhD
• Email: jiezhang8@hotmail.com
• Phone: 858-205-4558

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.