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

Metastatic Castration-resistant Prostate Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. Based on the "3 + 3" dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C). Additional subjects will be enrolled into the RP2D group to ensure that 6-9 efficacy-evaluable subjects are available in the RP2D group before entering the phase II study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06228404
Study type Interventional
Source Shanghai Changzheng Hospital
Contact Shancheng Ren, MD/PhD
Phone 139 1779 3885
Email renshancheng@gmail.com
Status Recruiting
Phase Early Phase 1
Start date March 3, 2024
Completion date December 2025
View Details
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