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

Exclusion Criteria

• •3. AbGn-168H (neihulizumab) therapy can begin not more than 14 days after diagnosis of aGvHD
• •4. Karnofsky Performance Status (KPS) \> 50%
• •5. No evidence of HCT graft failure or multi-organ failure
• •6. Ability to understand and the willingness to sign a written informed consent document
• •1. Uncontrolled infections not responsive to antimicrobial therapy requiring intensive critical care
• •2. Progressive malignant disease, including post-transplant lymphoproliferative disease unresponsive to therapy
• •3. Treatment with investigational GVHD prophylactic agents (eg, CCR5 inhibitors; lenalidomide; and/or bortezomib) within the 7 days prior to the 1st dose of neihulizumab
• •4. Treatment with other investigational agents within the prior 7 days prior to the 1st dose of AbGn-168H (neihulizumab)
• •5. CMV PCR \> 500 copies/mL or evidence of end-organ damage due to CMV
• •6. Pregnant or nursing
• •7. HIV positivity (NOTE: patients positive for hepatitis B or hepatitis C are not excluded, and may be evaluated on a case-by-case basis)
• •8. Renal clearance CCR \< 40 mL/min