A Study of AbGn-168H in Patients With Steroid Refractory Acute Graft-vs-Host Disease After Donor Stem Cell Transplant

Stopped early · Phase 1

Conditions studied: Acute Graft Versus Host Disease

In brief

This study is to establish the safety, determine if there is an improvement in steroid refractory acute graft-vs-host disease (aGvHD) compared to historical cohorts, and determine the changes of aGvHD-associated T-cell clones in patients with steroid-refractory aGVHD following allogeneic hematopoietic cell transplantation administered AbGn-168H once weekly for 4 weeks.

Key facts

Study ID

NCT02436460

Run by

AbGenomics B.V Taiwan Branch

People needed

4

Starts

2015-05-01

Expected to finish

2016-03-01

Last updated by the study team

2017-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of skin, gut and/or liver steroid-refractory GVHD by clinical assessment of treating physician following allogeneic HCT. Patients who fail to respond to steroids by 7 days are considered steroid-refractory
• Previously-treated with any conditioning regimen and any GVHD immune suppression prophylaxis and formulation of steroids, except as noted in Exclusion Criteria #2.
• AbGn-168H (neihulizumab) therapy can begin not more than 14 days after diagnosis of aGvHD
• Karnofsky Performance Status (KPS) > 50%
• No evidence of HCT graft failure or multi-organ failure
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

• Uncontrolled infections not responsive to antimicrobial therapy requiring intensive critical care
• Progressive malignant disease, including post-transplant lymphoproliferative disease unresponsive to therapy
• Treatment with investigational GVHD prophylactic agents (eg, CCR5 inhibitors; lenalidomide; and/or bortezomib) within the 7 days prior to the 1st dose of neihulizumab
• Treatment with other investigational agents within the prior 7 days prior to the 1st dose of AbGn-168H (neihulizumab)
• CMV PCR > 500 copies/mL or evidence of end-organ damage due to CMV
• Pregnant or nursing
• HIV positivity (NOTE: patients positive for hepatitis B or hepatitis C are not excluded, and may be evaluated on a case-by-case basis)
• Renal clearance CCR < 40 mL/min

Where it is running

• Stanford University, School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.