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

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

March 3, 2024

Primary Completion Date

May 31, 2025

Study Completion Date

December 31, 2025

Conditions
Metastatic Castration-resistant Prostate CancerCastration-resistant Prostate Cancer
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;"

Trial Locations (1)

201109

RECRUITING

Changzheng hospital, Shanghai

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bioray Laboratories

INDUSTRY

lead

Shanghai Changzheng Hospital

OTHER

NCT06228404 - Clinical Study of Safety and Efficacy of Enhanced PSMA CAR- T in Refractory CRPC | Biotech Hunter | Biotech Hunter