Status:
RECRUITING
Clinical Study of Safety and Efficacy of Universal PSMA CAR- T in Refractory CRPC
Lead Sponsor:
Shanghai Changzheng Hospital
Collaborating Sponsors:
Bioray Laboratories
Conditions:
Metastatic Prostate Cancer
Castration-resistant Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE1
Brief Summary
This is a single-arm, single-center, open-label clinical trial designed to evaluate the clinical safety and tolerability of different doses of Prostate-Specific Membrane Antigen (PSMA)-Universal Chime...
Detailed Description
This is a single-arm, single-center, open-label clinical trial, which aims to evaluate safety and clinical efficacy of different doses of PSMA-UCAR T (BRL-302) in treating patients with refractory CRP...
Eligibility Criteria
Inclusion
- Fully understood and voluntarily signed informed consent for this study;
- Male, aged 18-80 years;
- Expected survival of more than 6 months;
- 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;
- PSMA expression in tumor cells was positive in immunohistochemical staining of prostate/metastatic biopsy tissue before enrollment (within 6 months prior to enrollment);
- ECOG score \< 2 ;
- 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);
- 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
- Subjects meeting any of the following exclusion criteria will be excluded:
- Have received any previous treatment with CAR-T therapy ;
- Have received any previous treatment that targets PSMA;
- Tumor pathology suggests a special type of prostate cancer (e.g., neuroendocrine prostate cancer, etc.)
- Severe mental disorders;
- 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.
- 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;
- Active infectious disease or any major infectious event requiring high grade antibiotics;
- 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;
- Participation in other clinical studies in the past three months or previous treatment with any gene therapy product;
- Intolerance or hypersensitivity to cyclophosphamide or fludarabine chemotherapy;
- Unsuitability to participate in this clinical study in the opinion of the investigator.
Key Trial Info
Start Date :
March 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT06895811
Start Date
March 27 2025
End Date
November 1 2025
Last Update
April 11 2025
Active Locations (1)
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1
Changzheng hospital
Shanghai, Shanghai Municipality, China, 201109