NCT05426369

A Clinical Trial Evaluating SCB-219M in in Chemotherapy-induced Thrombocytopenia (CIT)

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Preliminary Efficacy and Pharmacokinetics of SCB-219M in the Patients With Chemotherapy-induced Thrombocytopenia

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Sichuan Clover Biopharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Preliminary Efficacy and Pharmacokinetics of SCB-219M in the patients with chemotherapy-induced thrombocytopenia (CIT)

Detailed description

The purpose of this trial is to evaluate the safety, tolerability, immunogenicity, and PK characteristics of single and multiple subcutaneous injections of SCB-219M for CIT, explore the MTD and BED, and preliminarily observe and evaluate efficacy. The trial is divided into a dose escalation phase (Ia) and an expansion phase (Ib).

Conditions

• Chemotherapy-induced Thrombocytopenia (CIT)

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein	Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein for injection (Strength: 1 mg/ml, 0.5ml/vial)

Timeline

• Start date: 2022-06-14
• Primary completion: 2025-07-02
• Completion: 2025-12-01
• First posted: 2022-06-22
• Last updated: 2025-07-31

Locations

1 site across 1 country: China