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Clinical Study of Safety and Efficacy of Enhanced PSMA CAR- T in Refractory CRPC
Sponsor: Shanghai Changzheng Hospital
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
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