RecruitingEarly Phase 1NCT06228404

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

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


Sponsor

Shanghai Changzheng Hospital

Enrollment

18 participants

Start Date

Mar 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is one center, single-arm, open-label investigator initiated trial to assess the safety and efficacy of enhanced autologous PSMA chimeric antigen receptor T cells in the treatment for patients with refractory castration resistant prostate cancer, and the sample size is set to 7-18 subjects.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an enhanced CAR-T cell therapy — a treatment that uses your own immune cells, genetically engineered to target a protein called PSMA found on prostate cancer cells — for men with advanced prostate cancer that has stopped responding to standard treatments. **You may be eligible if...** - You are a man between 18 and 75 with metastatic castration-resistant prostate adenocarcinoma (CRPC) - Your cancer has progressed on standard CRPC treatments (such as new hormone therapies, chemotherapy, or radium-223) - Your tumor biopsy shows positive PSMA expression - Your expected survival is more than 6 months - Your overall health is acceptable (ECOG score less than 2) **You may NOT be eligible if...** - Your tumor does not express PSMA - You have severe infections, autoimmune disease, or other serious health problems - Your organ function does not meet required thresholds - You have not yet progressed on standard CRPC treatments 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

DRUGEnhanced autologous PSMA-CAR T

3 escalated dosing cohorts are designed to explore safety and efficacy of enhanced autologous PSMA-CAR T: cohort A: CART-PSMA cells 0.25×106/kgBW, following lymphodepleting chemotherapy with cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day given according to protocol; cohort B: CART-PSMA cells 0.75×106/kgBW,following lymphodepleting chemotherapy with cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day given according to protocol; cohort C: CART-PSMA cells 2×106/kgBW,following lymphodepleting chemotherapy with cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day given according to protocol;


Locations(1)

Changzheng hospital

Shanghai, Shanghai Municipality, China

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NCT06228404


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