NCT05656573 CART-PSMA Cells for Advanced Prostate Cancer
| NCT ID | NCT05656573 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Nova Therapeutics LLC |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-03-01 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Jay Zhang
STUDY DIRECTOR
Nova Therapeutics LLC
Frequently Asked Questions
Who can join the NCT05656573 clinical trial?
This trial is open to male participants only, aged 35 Years or older, up to 85 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05656573 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05656573 currently recruiting?
Yes, NCT05656573 is actively recruiting participants. Contact the research team at jiezhang8@hotmail.com for enrollment information.
Where is the NCT05656573 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05656573 clinical trial?
NCT05656573 is sponsored by Nova Therapeutics LLC. The principal investigator is Jay Zhang at Nova Therapeutics LLC. The trial plans to enroll 20 participants.
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