drugset
drugset / Trial / NCT06193486

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

NCT06193486 ↗

Phase 1 Recruiting 30 enrolled H. Lee Moffitt Cancer Center and Research Institute
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2024-10-26
Primary completion
2029-01-13
Completion
2033-12-13

Drugs

EvaluationDrugModalityDoseRoute
Subject MSGV1-PSCA-8T28Z Cell therapy 100000 cells/kg —
Subject MSGV1-PSCA-8T28Z Cell therapy 300000 cells/kg —
Subject MSGV1-PSCA-8T28Z Cell therapy 1e+06 cells/kg —
Subject MSGV1-PSCA-8T28Z Cell therapy 3e+06 cells/kg —
Background Cyclophosphamide Other / unclassified 500 mg/m2 —
Background Fludarabine Small molecule 30 mg/m2 —

Indications

castration-resistant prostate carcinoma