A Phase 1 interventional study of AbGn-168H in Acute Graft Versus Host Disease, sponsored by AbGenomics B.V Taiwan Branch. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-30.
Sponsored by AbGenomics B.V Taiwan Branch · Phase 1, Interventional, and Treatment
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.
AbGn-168H is a humanized monoclonal antibody. This is a dose escalation study using a modified toxicity probability interval method. AbGn-168H will be administered intravenously (IV) once weekly for four weeks, in patients with steroid refractory aGVHD following hematopoietic cell transplant (HCT). After completion of study treatment, patients are followed up for 90 days.The primary objective of this study is to establish the safety, and the secondary objectives of this study are to determine if there is an improvement in disease response at 3 months after diagnosis of steroid refractory aGVHD compared to historical cohorts and to determine the changes in frequency and/or phenotype of aGVHD-associated T cell clones in response to AbGn-168H therapy.
806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's enrollment of 4 is below the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →AbGenomics B.V Taiwan Branch is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
AbGn-168H will be administered once weekly for four weeks via intravenous infusion.
Biological: AbGn-168H
Humanized monoclonal antibody
Also known as: Neihulizumab
Adverse events
Grade 3 to 5 adverse events considered at least possibly-related to neihulizumab
Time frame: On or before study day 52
Cytokine release syndrome or acute infusion reactions
Grade 3 to 5 cytokine release syndrome or acute infusion reactions
Time frame: Within 24 hours after study drug infusion
Neutropenia
Grade 4 neutropenia lasting more than 14 days considered at least possibly related to study drug
Time frame: Duration of study
All-cause mortality
Grade 5 all-cause mortality
Time frame: Within 7 days of infusion
Changes in frequency and/or phenotype of aGVHD-associated T-cell clones
Changes in T cell clonal dynamics will be accomplished by statistical methodology.
Time frame: At time of diagnosis up to 90 days
GVHD treatment response as measured by the Modified Keystone aGVHD clinical grade scale
Treatment response will be estimated by the Kaplan Meier product limit method, with standard confidence limits
Time frame: At 90 days after the diagnosis of aGVHD
Plan to share: No
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This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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AbGenomics B.V Taiwan Branch