Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
18

Summary

Conditions
Metastatic Castration Resistant Prostate Cancer
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Sequential AssignmentIntervention Model Description: Sequential dose escalationMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

This is a Phase 1 single-arm study designed to identify the dose and regimen of CART-PSMA- TGF?RDN cells that can be safely administered intravenously following the lymphodepletion (LD) regimen to patients with metastatic castration resistant prostate cancer (mCRPC). Following Dose Escalation, a Coh...

This is a Phase 1 single-arm study designed to identify the dose and regimen of CART-PSMA- TGF?RDN cells that can be safely administered intravenously following the lymphodepletion (LD) regimen to patients with metastatic castration resistant prostate cancer (mCRPC). Following Dose Escalation, a Cohort Expansion will enroll patients to further explore the safety and tolerability of the selected dose and schedule. It is anticipated that up to 50 patients will enroll in this study in both dose escalation and cohort expansion.

Tracking Information

NCT #
NCT04227275
Collaborators
Not Provided
Investigators
Not Provided