Clinical Study of Safety and Efficacy of Universal PSMA CAR- T in Refractory CRPC (NCT06895811) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Clinical Study of Safety and Efficacy of Universal PSMA CAR- T in Refractory CRPC
China3 participantsStarted 2025-03-27
Plain-language 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 Chimeric Antigen Receptor (UCAR) T-lymphocytes (PSMA-UCAR T) for the treatment of patients with refractory castration-resistant prostate cancer (CRPC).
Who can participate
Age range18 Years – 80 Years
SexMALE
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Inclusion criteria
✓. Fully understood and voluntarily signed informed consent for this study;
✓. 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 criteria
✕. 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;
What they're measuring
1
The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Timeframe: Through 6 months after CAR T cell infusion
2
Cytokine Release Syndrome (CRS) grading post CAR T cell infusion.
Timeframe: Through 6 months after CAR T cell infusion
. 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;