NCT04053062

LIGHT-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer

A Phase I Study to Evaluate the Safety and Efficacy of PSMA-CART Co-expressing LIGHT in Treating Patients With Castrate-Resistant Prostate Cancer (CRPC)

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Bioray Laboratories · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, single arm Phase I study to establish the safety and efficacy of intravenously administered lentivirally transduced LIGHT-PSMA-specific CAR modified autologous T cells (PSMA-CART cells) in patients with CRPC.

Detailed description

This is a Phase I study evaluating the safety and efficacy of PSMA targeting autologous CAR T cells co-expressing LIGHT in a 3+3 dose escalation design. Cohort 1 subjects (N=3 or 6) will receive a tolal dose of 3x 10\^6/kg body weight (KgBW) LIGHT-PSMA-CART cells at split doses after a conditioning chemotherapeutic regimen(Cy+Flu). If 1 DLT/3 subjects occurs, the study will enroll an additional 3 subjects at this dose level. If 0 DLT/3 subjects or 1 DLT/6 subjects occurs, the study will advance to Cohort 2, with a total dose of 6 x 10\^6/ KgBW.

Conditions

• Castrate-Resistant Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	LIGHT-PSMA-CART cells	LIGHT-PSMA-CART cells will be given IV at split doses

Timeline

• Start date: 2020-07-16
• Primary completion: 2022-05-15
• Completion: 2024-10-15
• First posted: 2019-08-12
• Last updated: 2024-01-05

Locations

1 site across 1 country: China