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NCT06895811
PHASE1

Clinical Study of Safety and Efficacy of Universal PSMA CAR- T in Refractory CRPC

Sponsor: Shanghai Changzheng Hospital

View on ClinicalTrials.gov

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).

Official title: The Safety and Efficacy Evaluation of Universal PSMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory Castration Resistant Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2025-03-27

Completion Date

2026-11

Last Updated

2026-04-28

Healthy Volunteers

No

Interventions

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.

Locations (1)

Changzheng hospital

Shanghai, Shanghai Municipality, China