NCT07259889

Safety and Tolerability Evaluation of CEL001 Injection in Advanced Solid Tumors

A Phase I Clinical Study Evaluating the Safety and Tolerability of CEL001 Injection in the Treatment of Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: Guangzhou Xiling Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is the first human, open label, dose escalation, and expansion phase I clinical trial aimed at evaluating the safety, tolerability, preliminary efficacy, pharmacokinetic characteristics, biomarker changes, and immunogenicity of CEL001 injection in the treatment of advanced solid tumors.

Detailed description

This study is divided into five stages: screening period, single dose period, clearing period, multiple dose period, and follow-up period. The observation period for single dose DLT is tentatively set at 14 days after administration, while the observation period for multiple dose DLT is tentatively set at 28 days after the first dose of multiple doses. The cumulative administration time from a single dose is tentatively set at no more than 1 year, and the follow-up period is tentatively set at 2 years after the last dose.

Conditions

• Advanced Solid Tumors (Phase 1)

Interventions

Type	Name	Description
DRUG	NK cell preparation	CEL001 injection

Timeline

• Start date: 2025-06-16
• Primary completion: 2028-06-15
• Completion: 2028-06-15
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: China