Neihulizumab for Graft-versus-Host Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Graft-versus-Host DiseaseNeihulizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is to test a new drug, Neihulizumab, to see if it is safe and tolerated by patients with aGVHD.

Eligible Conditions
  • Graft-versus-Host Disease

Treatment Effectiveness

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 6 months

6 months
Event-free survival.
Non-relapse mortality.
Day 28
Number of DLTs.
Treatment response: Complete response
Treatment response: Partial response
Use of High Dose Steroids
Up to 28 days
Maximum-tolerated dose.

Trial Safety

Trial Design

4 Treatment Groups

Neihulizumab Dose Escalation, 3 mg/kg
1 of 4
Neihulizumab Dose Escalation, 9 mg/kg
1 of 4
Neihulizumab Dose Expansion
1 of 4
Neihulizumab Dose Escalation, 6 mg/kg
1 of 4

Experimental Treatment

16 Total Participants · 4 Treatment Groups

Primary Treatment: Neihulizumab · No Placebo Group · Phase 1

Neihulizumab Dose Escalation, 3 mg/kg
Biological
Experimental Group · 1 Intervention: Neihulizumab, 3 mg/kg · Intervention Types: Biological
Neihulizumab Dose Escalation, 9 mg/kg
Drug
Experimental Group · 1 Intervention: Neihulizumab, 9 mg/kg · Intervention Types: Drug
Neihulizumab Dose Expansion
Drug
Experimental Group · 1 Intervention: Neihulizumab · Intervention Types: Drug
Neihulizumab Dose Escalation, 6 mg/kg
Drug
Experimental Group · 1 Intervention: Neihulizumab, 6 mg/kg · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

Sameem M. Abedin, MDLead Sponsor
Sameem Abedin, MDPrincipal InvestigatorMedical College of Wisconsin
3 Previous Clinical Trials
80 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a stage 1-3 skin plus stage 1 upper GI.
You have stage 1-3 skin plus stage 1 lower GI.
You have a minimum of stage 1 skin plus stage 1 lower GI plus stage 1 upper GI.
You have stage 1-3 skin and stage 1-4 liver.