A Study of CART-PSMA-TGF?RDN in Patients With Metastatic Castration Resistant Prostate Cancer
Last updated on July 2021Recruitment
- 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