Education and Training
A Study of AbGn-168H in Patients With Steroid Refractory Acute Graft-vs-Host Disease After Donor Stem Cell Transplant
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.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- biological: AbGn-168H
Eligibility
Inclusion Criteria:
1. 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
2. Previously-treated with any conditioning regimen and any GVHD immune suppression
prophylaxis and formulation of steroids, except as noted in Exclusion Criteria #2.
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
Exclusion Criteria:
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO Office
650-498-7061
Not Recruiting