NCT04144036View on ClinicalTrials.gov

Neihulizumab for Standard-Risk Acute Graft Versus Host Disease (GVHD)

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

December 14, 2020

Primary Completion Date

April 20, 2023

Study Completion Date

July 7, 2024

Conditions
Graft-versus-host Disease
Interventions
BIOLOGICAL

Neihulizumab, 3 mg/kg

The doses for the 3 + 3 design (dose escalation phase) are listed in the arm description. The dose-expansion phase will use the maximum-tolerated dose.

DRUG

Neihulizumab, 6 mg/kg

The doses for the 3 + 3 design (dose escalation phase) are listed in the arm description. The dose-expansion phase will use the maximum-tolerated dose.

DRUG

Neihulizumab, 9 mg/kg

The doses for the 3 + 3 design (dose escalation phase) are listed in the arm description. The dose-expansion phase will use the maximum-tolerated dose.

DRUG

Neihulizumab

This arm will receive the Maximum Tolerated Dose determined in the Drug Escalation phase.

Trial Locations (1)

53226

Froedtert Hospital and the Medical College of Wisconsin, Milwaukee

All Listed Sponsors
lead

Sameem M. Abedin, MD

OTHER

NCT04144036 - Neihulizumab for Standard-Risk Acute Graft Versus Host Disease (GVHD) | Biotech Hunter | Biotech Hunter