Using modified T cells to treat advanced prostate cancer

Phase I Study of CART-PSMA Cells in Patients With Advanced Prostate Cancer

This study is testing a new treatment using modified immune cells to see if it can help people with advanced prostate cancer feel better and tolerate the therapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 35 Years to 85 Years
• Sex: Male
• Sponsor: Nova Therapeutics LLC (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, CART
• Locations: 1 site (Beijing)
• Trial ID: NCT05656573 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with histologically confirmed advanced prostate cancer that expresses PSMA.

Not a fit: Patients with prostate cancer that does not express PSMA or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel and effective option for patients with advanced prostate cancer.

How similar studies have performed: Other studies using CAR T-cell therapies have shown promising results in various cancers, suggesting potential success for this approach in prostate cancer.

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.

Where this trial is running

Beijing

• Chinese PLA General Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Jay Zhang, MD/PhD

Conditions Prostate Cancer