NCT06193486

Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC

A Phase I Clinical Trial of an Infusion of Autologous Gamma Delta T Cells Genetically Engineered With a Chimeric Receptor to Target the Prostate Stem Cell Antigen in Patients With Metastatic Castration Resistant Prostate Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1 single center clinical trial for patients with end stage Metastatic Castration Resistant Prostate Cancer who have progressed through standard of care treatment options and are on zoledronate for bone metastases. This clinical trial includes a dose-escalation phase and dose-expansion phase to assess the safety and preliminary efficacy of treatment with autologous T cells genetically modified to express Prostate stem cell antigen.

Conditions

• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	MSGV1-PSCA-8T28Z	Autologous Gamma Delta T Cells Genetically Engineered with a Chimeric Receptor to Target the Prostate Stem Cell Antigen.
DRUG	Fludarabine	Fludarabine is an antimetabolite given prior to lymphodepletion.
DRUG	Cyclophosphamide	Cyclophosphamide is a nitrogen mustard-derivative, polyfunctional alkylating agent given prior to lymphodepletion.

Timeline

• Start date: 2024-10-26
• Primary completion: 2029-01-13
• Completion: 2033-12-13
• First posted: 2024-01-05
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study