NCT05258331

Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With Psoriasis

An Open-label, Dose-escalation, Phase 1 Trial to Investigate the Safety, Tolerability, and Efficacy After Single- and Multiple-dose Administration of CT303 in Patients With Moderate to Severe Plaque Psoriasis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: GC Cell Corporation · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Investigate the Safety, Tolerability, Efficacy and pharmacodynamics properties of CT303 in patients with moderate to severe plaque psoriasis

Detailed description

This study is a multi-center, open-label, dose-escalation and dose-finding phase 1 clinical trial. The primary purpose is to evaluate the safety and tolerability of CT303 and the secondary purpose is to evaluate the safety and efficacy of CT303 in patients with moderate to severe plaque psoriasis.

Conditions

• Moderate to Severe Plaque Psoriasis

Interventions

Type	Name	Description
GENETIC	CT303	1. Cohort 1 : Single-dose administration, intravenous injection * Dose 1(Starting dose) : 1.0\*10\^6 cells/kg * Dose 2 : 2.0\*10\^6 cells/kg * Dose 3 : 3.0\*10\^6 cells/kg 2. Cohort 2 : Multiple-dose administration, intravenous injections (Week 0, Week 4) * Dose 1(Starting dose) : 1.0\*10\^6 cells/kg * Dose 2 : 2.0\*10\^6 cells/kg * Dose 3 : 3.0\*10\^6 cells/kg

Timeline

• Start date: 2021-10-25
• Primary completion: 2024-08-30
• Completion: 2024-12-30
• First posted: 2022-02-28
• Last updated: 2022-03-18

Locations

3 sites across 1 country: South Korea