NCT04539470

Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

A Phase Ib, Open-Label, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ib, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of Efmarodocokin Alfa and to make a preliminary assessment of activity of Efmarodocokin Alfa in combination with standard-of-care (SOC) in the prevention of acute graft-versus-host disease (aGVHD) in participants undergoing allogeneic hematopoietic stem cell transplantation (HSCT).

Conditions

• Acute Graft-versus-host Disease

Interventions

Type	Name	Description
DRUG	Efmarodocokin Alfa	Efmarodocokin Alfa will be administered intravenously (IV) per the dosage specified in each dose escalation cohort.

Timeline

• Start date: 2020-11-19
• Primary completion: 2023-02-24
• Completion: 2023-02-24
• First posted: 2020-09-07
• Last updated: 2024-04-11

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study