A Phase 1 interventional study of PSMA-UCAR T (BRL-302) in Metastatic Prostate Cancer, Castration-resistant Prostate Cancer and Metastatic Castration-resistant Prostate Cancer, sponsored by Shanghai Changzheng Hospital. Active, not recruiting at 1 site in China. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Shanghai Changzheng Hospital · Phase 1, Interventional, and Treatment
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).
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 CRPC.
Three patients will be firstly enrolled at a dose level (DL) of 5.0 × 10\^6cells/kg in the DL1 group. Based on preliminary safety data, efficacy information, and PK/PD parameters obtained at DL1 cohort, the investigator may enroll another three patients in a decreased dose level group of DL-2: 3 × 10\^6 cells/kg or DL-1:1 × 10\^6 cells/ kg, after thorough discussions between the investigators.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 3 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Shanghai Changzheng Hospital is the lead sponsor of 125 studies on the registry; 60 are open to participants now.
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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;
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria will be excluded:
Biological: PSMA-UCAR T (BRL-302)
Three patients will be firstly enrolled at a dose level (DL) of 5.0 × 10\^6cells/kg in the DL1 group, following lymphodepleting chemotherapy which will be given under instruction of protocol and investigators' assessment; Based on preliminary safety data, efficacy information, and PK/PD parameters obtained at DL1 cohort, the investigator may enroll another three patients in a decreased dose level group of DL-2: 3 × 10\^6 cells/kg or DL-1:1 × 10\^6 cells/ kg, after thorough discussions between the investigators.
The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Safety assessment: toxicity profile
Time frame: Through 6 months after CAR T cell infusion
Cytokine Release Syndrome (CRS) grading post CAR T cell infusion.
Safety assessment: toxicity profile
Time frame: Through 6 months after CAR T cell infusion
Safety assessment: dose-limiting toxicity
Incidence of dose-limiting toxicity (DLT) within 28 days. Dose-limiting toxicity (DLT) is defined as any relevant adverse event that ≥ grade 3 and did not resolve to a grade ≤ grade 2 within 28 days after the first infusion back.
Time frame: 28 days after CAR T cell infusion
Efficacy assessment: PSA changes
Prostate-Specific Antigen (PSA) changes assessed by serum PSA measurement (ng/ml).
Time frame: 6 months after CAR T cell infusion
Efficacy assessment: radiographic Progression-Free Survival (rPFS)
rPFS is defined as the time between treatment with study drug and the development of imaging progression or death from any cause, whichever occurs first, with imaging progression encompassing the evaluation of progression of primary lesions, non-regional lymph node invasion, soft tissue metastases, and bone metastatic lesions according to RECIST 1.1 and PCWG3 criteria.
Time frame: 6 months after CAR T cell infusion
6-months Progression-Free Survival (PFS)
PFS is defined as the time between treatment with study drug and disease progression or death from any cause, whichever occurs first, including biochemical progression or radiographic progression after evaluation according to RECIST 1.1 and PCWG3 criteria according to the included.
Time frame: 6 months after CAR T cell infusion
Pharmacokinetics (PK) assessment: expansion of CAR T cells
With the day of the first infusion of the cellular preparation recorded as D0, the monitoring phase of the pharmacokinetic study started from 1 day before the first infusion (D-1). Expansion of CAR T cells will be assessed by concentration profile of CAR-T cells in peripheral blood after PSMA-UCAR T infusion.
Time frame: From Day 1 till at least 3 months after CAR T cell infusion
Pharmacokinetics (PK) assessment: persistence of CAR T cells
With the day of the first infusion of the cellular preparation recorded as D0, the monitoring phase of the pharmacokinetic study started from 1 day before the first infusion (D-1). Persistence of CAR T cells will be assessed by T-cell survival time (area under the curve AUC0-28 at 28 days and area under the curve AUC0-90 at 90 days);
Time frame: From Day 1 till at least 3 months after CAR T cell infusion
Pharmacodynamics (PD) assessment eg. (Level of IL-6)
Pharmacokinetic (PD) endpoints is assessed by changes in serum cytokine levels (eg.IL-6) after PSMA-UCAR T infusion.
Time frame: From Day 1 till at least 3 months after CAR T cell infusion
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Changzheng Hospital