Clinical Study of Safety and Efficacy of Universal PSMA CAR- T in Refractory CRPC
Launched by SHANGHAI CHANGZHENG HOSPITAL · Mar 25, 2025
Trial Information
Current as of April 23, 2025
Recruiting
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.
Trial Officials
Shancheng Ren, MD, PhD
Principal Investigator
Shanghai Changzheng Hospital
About Shanghai Changzheng Hospital
Shanghai Changzheng Hospital, affiliated with the Second Military Medical University, is a leading medical institution in China known for its comprehensive clinical services and advanced research capabilities. With a commitment to improving patient outcomes and advancing medical knowledge, the hospital actively engages in clinical trials across various therapeutic areas. Its multidisciplinary team of healthcare professionals collaborates with researchers and industry partners to facilitate innovative studies, ensuring adherence to the highest ethical and regulatory standards. By leveraging its state-of-the-art facilities and expertise, Shanghai Changzheng Hospital aims to contribute significantly to the development of new treatments and therapies that enhance patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported