Clinical Study of Safety and Efficacy of Universal PSMA CAR- T in Refractory CRPC

Launched by SHANGHAI CHANGZHENG HOSPITAL · Mar 25, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for men with advanced prostate cancer that has not responded to standard therapies. The treatment involves using specially modified immune cells called PSMA-UCAR T-lymphocytes, which are designed to target cancer cells that express a protein called Prostate-Specific Membrane Antigen (PSMA). The goal of the study is to assess the safety and how well different doses of this treatment work for patients with castration-resistant prostate cancer, meaning their cancer continues to grow despite hormone therapy.

To participate in this trial, men aged 18 to 80 who have been diagnosed with metastatic castration-resistant prostate cancer may be eligible, especially if they have already tried other treatments without success. Participants must also have a good understanding of the trial and be able to give their consent. Throughout the study, participants will receive the PSMA-UCAR T treatment, and doctors will closely monitor their health and how their cancer responds. It’s important to know that this is an early-stage trial, which means researchers are still learning about the treatment's effects and safety.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Fully understood and voluntarily signed informed consent for this study;
• • 2. Male, aged 18-80 years;
• • 3. Expected survival of more than 6 months;
• 4. Metastatic castration-resistant prostate adenocarcinoma (CRPC) patients:
• • Have received CRPC standard treatment (such as novel hormone therapies, chemotherapy and radium-223, etc., one or more of the combination therapy) after the diagnosis of CRPC, and is ineffective or progressive :PSA continued rising for 3 months, or bone scan/whole-body MRI/PET-CT showed local recurrence or new metastatic lesions, demonstrating disease progression;
• • 5. PSMA expression in tumor cells was positive in immunohistochemical staining of prostate/metastatic biopsy tissue before enrollment (within 6 months prior to enrollment);
• • 6. ECOG score \< 2 ;
• • 7. Virological examination HAV (hepatitis A virus), HBV (hepatitis B virus), HCV (hepatitis C virus), HIV (human immunodeficiency virus), TP (Treponema pallidum) quantitative detection was negative, (antigen and antibody screening method unknown, confirmed by nucleic acid method);
• • 8. Hematological parameters met the following criteria: a. hemoglobin \> 100 g/L; b. platelet count \> 100 × 10\^9/L; c. neutrophils \> 1.5 × 10\^9/L.
• Exclusion Criteria:
• Subjects meeting any of the following exclusion criteria will be excluded:
• • 1. Have received any previous treatment with CAR-T therapy ;
• • 2. Have received any previous treatment that targets PSMA;
• • 3. Tumor pathology suggests a special type of prostate cancer (e.g., neuroendocrine prostate cancer, etc.)
• • 4. Severe mental disorders;
• • 5. Suffered from previous malignancies, except for the following: a. basal cell carcinoma or squamous cell carcinoma after standardized treatment; b. having a primary malignancy, but completely resected, with a complete remission time of ≥ 5 years.
• • 6. Subjects with severe cardiovascular disease; a.New York Heart Association (NYHA) stage III or IV congestive heart failure; b.Myocardial infarction ≤ 6 months prior to enrollment or coronary artery bypass graft (CABG); c.Clinically significant ventricular arrhythmia, or history of unexplained syncope, nonvasovagal or not due to dehydration; d.History of severe non-ischemic cardiomyopathy; e.Decreased left ventricular ejection fraction (LVEF \< 55%) as assessed by echocardiogram or multigated acquisition (MUGA) scan, abnormal interventricular septal thickness and atrioventricular size associated with myocardial amyloidosis;
• • 7. Active infectious disease or any major infectious event requiring high grade antibiotics;
• • 8. Organ function in the following abnormalities: a. serum aspartate aminotransferase or alanine aminotransferase \> 2.5\*Upper Limit of Normal (ULN); CK \> ULN; CK-MB \> ULN; TnT \> 1.5\*ULN; b. total bilirubin \> 1.5\*ULN; c. partial prothrombin time or activated partial thromboplastin time or international normalized ratio \> 1.5\*ULN in the absence of anticoagulant therapy;
• • 9. Participation in other clinical studies in the past three months or previous treatment with any gene therapy product;
• • 10. Intolerance or hypersensitivity to cyclophosphamide or fludarabine chemotherapy;
• • 11. Unsuitability to participate in this clinical study in the opinion of the investigator.