Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Neoplasms Prostate
  • Genital Neoplasms, Male
  • Metastatic Castration Resistant Prostate Cancer
  • Neoplasms
  • Neoplasms by Histologic Type
  • Neoplasms by Site
  • Prostate Cancer
  • Prostatic Disease
  • Prostatic Neoplasms
  • Prostatic Neoplasms, Castration-Resistant
  • Urogenital Neoplasms
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Open label, 3 + 3 design of dose-escalating cohorts with open label, dose expansion at RP2DMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

This is an open label, multi-center Phase 1 study that will follow a 3 + 3 design of dose-escalating cohorts of single and multiple doses of P-PSMA-101 to determine a Recommended Phase 2 Dose (RP2D). Additional participants will be treated with P-PSMA-101 at the determined RP2D. Following consent, e...

This is an open label, multi-center Phase 1 study that will follow a 3 + 3 design of dose-escalating cohorts of single and multiple doses of P-PSMA-101 to determine a Recommended Phase 2 Dose (RP2D). Additional participants will be treated with P-PSMA-101 at the determined RP2D. Following consent, enrolled participants will undergo a leukapheresis procedure to obtain peripheral blood mononuclear cells (PBMCs) which will be sent to a manufacturing site to produce P-PSMA-101 CAR-T cells. The cells will then be returned to the investigational site and administered after a lymphodepleting chemotherapy regimen. Rimiducid may be administered as indicated.

Tracking Information

NCT #
NCT04249947
Collaborators
Not Provided
Investigators
Study Director: Matthew Spear, M.D. Sponsor Chief Medical Officer
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