OncoMatch/Clinical Trials/NCT06895811
Clinical Study of Safety and Efficacy of Universal PSMA CAR- T in Refractory CRPC
Is NCT06895811 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies PSMA-UCAR T (BRL-302) for metastatic prostate cancer.
Treatment: PSMA-UCAR T (BRL-302) — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 overexpression (positive in immunohistochemical staining)
PSMA expression in tumor cells was positive in immunohistochemical staining of prostate/metastatic biopsy tissue before enrollment (within 6 months prior to enrollment)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: CRPC standard treatment (novel hormone therapies, chemotherapy, radium-223) — CRPC
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
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 > 1.5*ULN in the absence of anticoagulant therapy
Liver function
serum aspartate aminotransferase or alanine aminotransferase > 2.5*ULN; CK > ULN; CK-MB > ULN; TnT > 1.5*ULN; total bilirubin > 1.5*ULN
Cardiac function
NYHA stage III or IV congestive heart failure; myocardial infarction ≤ 6 months prior to enrollment or CABG; clinically significant ventricular arrhythmia, or history of unexplained syncope, nonvasovagal or not due to dehydration; history of severe non-ischemic cardiomyopathy; decreased LVEF (< 55%) as assessed by echocardiogram or 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 > 2.5*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. Severe cardiovascular disease: NYHA stage III or IV congestive heart failure; myocardial infarction ≤ 6 months prior to enrollment or CABG; clinically significant ventricular arrhythmia, or history of unexplained syncope, nonvasovagal or not due to dehydration; history of severe non-ischemic cardiomyopathy; decreased LVEF (< 55%) as assessed by echocardiogram or 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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