Treatment of refractory metastatic prostate cancer using PSMA CAR-T cells
The Safety and Efficacy Evaluation of Universal PSMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory Castration Resistant Prostate Cancer
This study is testing a new type of immune cell treatment for men with hard-to-treat prostate cancer to see if it can help them feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Shanghai Changzheng Hospital Academic / other |
| Drugs / interventions | CAR-T, chemotherapy, cyclophosphamide, fludarabine, Chimeric Antigen Receptor |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06895811 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of Prostate-Specific Membrane Antigen Universal Chimeric Antigen Receptor T-lymphocytes (PSMA-UCAR T) in patients with refractory castration-resistant prostate cancer (CRPC). It is a single-arm, open-label study where patients will receive different doses of PSMA-UCAR T cells. The trial will begin with three patients at a dose level of 5.0 × 10^6 cells/kg, with potential adjustments based on safety and efficacy data. The goal is to determine the tolerability and clinical outcomes of this innovative treatment approach.
Who should consider this trial
Good fit: Ideal candidates are males aged 18-80 with metastatic castration-resistant prostate adenocarcinoma who have experienced disease progression despite standard treatments.
Not a fit: Patients who do not express PSMA in their tumor cells or have an ECOG score of 2 or higher may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer that is resistant to standard therapies.
How similar studies have performed: While CAR-T therapies have shown promise in other cancers, this specific application in metastatic castration-resistant prostate cancer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai
- Changzheng hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Shancheng Ren, MD, PhD — Shanghai Changzheng Hospital
- Study coordinator: Shancheng Ren, MD, PhD
- Email: renshancheng@gmail.com
- Phone: 139 1779 3885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.