OncoMatch/Clinical Trials/NCT06228404
Clinical Study of Safety and Efficacy of Enhanced PSMA CAR- T in Refractory CRPC
Is NCT06228404 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Enhanced autologous PSMA-CAR T for metastatic castration-resistant prostate cancer.
Treatment: Enhanced autologous PSMA-CAR T — This is one center, single-arm, open-label investigator initiated trial to assess the safety and efficacy of enhanced autologous PSMA chimeric antigen receptor T cells in the treatment for patients with refractory castration resistant prostate cancer, and the sample size is set to 7-18 subjects.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 positive expression (positive)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: CRPC standard treatment (new endocrine therapy, chemotherapy, radium-223) — after the diagnosis of CRPC
Receiving CRPC standard treatment (such as new endocrine therapy, chemotherapy and radium-223, etc., one or more of the combination therapy) after the diagnosis of CRPC, ineffective or progressive disease
Cannot have received: CAR-T cell therapy
have received any previous treatment with CAR-T therapy
Cannot have received: PSMA-targeted therapy
have received any previous treatment that targets PSMA
Cannot have received: gene therapy
previous treatment with any gene therapy product
Lab requirements
Blood counts
hemoglobin > 100 g/L; platelet count > 100 × 10^9/L; neutrophils > 1.5 × 10^9/L; partial prothrombin time or activated partial thromboplastin time or international normalized ratio > 1.5ULN in the absence of anticoagulant therapy
Liver function
serum aspartate aminotransferase or alanine aminotransferase > 2.5ULN; CK > ULN; CK-MB > ULN; TnT > 1.5ULN; total bilirubin > 1.5ULN
Cardiac function
NYHA stage III or IV congestive heart failure; myocardial infarction ≤ 6 months prior to enrollment or coronary artery bypass graft (CABG); clinically significant ventricular arrhythmia, or history of unexplained syncope, nonvasovagal or not due to dehydration; history of severe non-ischemic cardiomyopathy; 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
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. organ function in the following abnormalities: a. serum aspartate aminotransferase or alanine aminotransferase > 2.5ULN; CK > ULN; CK-MB > ULN; TnT > 1.5ULN; b. total bilirubin > 1.5ULN; c. partial prothrombin time or activated partial thromboplastin time or international normalized ratio > 1.5ULN in the absence of anticoagulant therapy; cardiac: NYHA stage III or IV congestive heart failure; myocardial infarction ≤ 6 months prior to enrollment or coronary artery bypass graft (CABG); clinically significant ventricular arrhythmia, or history of unexplained syncope, nonvasovagal or not due to dehydration; history of severe non-ischemic cardiomyopathy; 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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