NCT06296095

To Evaluate the Clinical Study of CUD005 Injection in Patients With Cirrhosis

A Single-center, Single-arm, Open-label, Dose-escalation Clinical Study Evaluating the Safety, Tolerability, and Initial Efficacy of CUD005 Injection in Patients With Cirrhosis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is a single-center, single-arm, open-label, dose-escalation clinical study, to evaluate the tolerability, safety and preliminary efficacy of CUD005 injection in patients with cirrhosis

Detailed description

The study was designed according to the 3+3 principle, with a total of 3 dose levels and dose escalation. Low-dose group: 5.0×107 cells/time; Medium-dose group: 1.5×108 cells/time; High-dose group: 5.0×108 cells/time. Subjects were sequentially placed in 3 different dose groups administered as a single peripheral intravenous dose. According to the enrollment restriction design, a total of a minimum of 9 subjects are expected to be enrolled, and the final sample size depends on the number of DLT, the number of dose groups ascended before DLT is observed, and the MTD is determined.

Conditions

• Cirrhosis, Liver

Interventions

Type	Name	Description
BIOLOGICAL	Cell therapy	Subjects were placed sequentially into three different dose groups, 5.0×107 cells/time (low-dose group), 1.5×108 cells/time (medium-dose group), and 5.0×108 cells/time (high-dose group) for dose escalation

Timeline

• Start date: 2023-08-09
• Primary completion: 2024-10-31
• Completion: 2024-12-31
• First posted: 2024-03-06
• Last updated: 2024-03-06

Locations

1 site across 1 country: China