RecruitingPhase 1NCT06895811

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

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


Sponsor

Shanghai Changzheng Hospital

Enrollment

3 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of cell therapy called Universal PSMA CAR-T for men with advanced prostate cancer that no longer responds to standard hormone treatments (called castration-resistant prostate cancer, or CRPC). CAR-T therapy involves modifying immune cells to target a protein called PSMA that is found on prostate cancer cells. This is an early-phase study to assess safety and early signs of effectiveness. **You may be eligible if...** - You are a male between 18 and 80 years old - You have metastatic castration-resistant prostate cancer (cancer that has spread and no longer responds to hormone therapy) - You have already received one or more standard CRPC treatments (such as hormone therapies, chemotherapy, or radium-223) - Your expected survival is more than 6 months - Your general health and organ function meet the study requirements **You may NOT be eligible if...** - You have active autoimmune disease or a compromised immune system - You have uncontrolled infections - You have received certain prior treatments that would interfere with CAR-T therapy - You have significant heart, lung, liver, or kidney problems - You have active brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPSMA-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

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NCT06895811


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