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RECRUITING
NCT06228404
EARLY_PHASE1

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

Sponsor: Shanghai Changzheng Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2024-03-03

Completion Date

2025-12

Last Updated

2024-04-18

Healthy Volunteers

No

Interventions

DRUG

Enhanced 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