RecruitingPhase 1NCT06046040

TmPSMA-02 in mCRPC

Phase I, Open-Label Study of Dually Armored Chimeric Antigen Receptor (CAR) T Cells (TmPSMA-02) in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC)


Sponsor

University of Pennsylvania

Enrollment

30 participants

Start Date

Jan 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase I, open-label dose finding study to assess the safety, tolerability, manufacturing feasibility, and preliminary efficacy of TmPSMA-02 CAR T cells in patients with metastatic castrate-resistant prostate cancer (mCRPC). Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests TmPSMA-02, a targeted radiation therapy that delivers radioactive material directly to prostate cancer cells using a molecule that seeks out a protein called PSMA. It is being studied in men with metastatic prostate cancer that no longer responds to hormone therapy (called mCRPC). **You may be eligible if...** - You are a man with metastatic prostate cancer that has stopped responding to hormone treatments - Your cancer tests positive for the PSMA protein on imaging - You have received prior standard treatments - Your kidneys and other organs are functioning well enough **You may NOT be eligible if...** - Your cancer does not show adequate PSMA expression - You have had too much prior radiation to certain organs - You have significant kidney disease - You are on certain other cancer treatments that cannot be paused 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTmPSMA-02 CAR T Cells

TmPSMA-02 CAR T cells: autologous T cells transduced with a lentiviral vector to express an anti-PSMA CAR containing a humanized J591-derived scFv and CD2 co-stimulatory domain, and dually armored with a TGFβRDN and PD1.CD28 switch receptor.


Locations(1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06046040


Related Trials