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

NCT02436460 | Terminated Phase 1 DMC

• 4 other identifiers: BMT 285NCI-2015-00631IRB-32842348
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Graft Versus Host Disease

Outcome Measures

Primary Outcomes (4)

• Adverse events

  Grade 3 to 5 adverse events considered at least possibly-related to neihulizumab

  On or before study day 52

• Cytokine release syndrome or acute infusion reactions

  Grade 3 to 5 cytokine release syndrome or acute infusion reactions

  Within 24 hours after study drug infusion

• Neutropenia

  Grade 4 neutropenia lasting more than 14 days considered at least possibly related to study drug

  Duration of study

• All-cause mortality

  Grade 5 all-cause mortality

  Within 7 days of infusion

Secondary Outcomes (2)

• Changes in frequency and/or phenotype of aGVHD-associated T-cell clones

  At time of diagnosis up to 90 days

• GVHD treatment response as measured by the Modified Keystone aGVHD clinical grade scale

  At 90 days after the diagnosis of aGVHD

Study Arms (1)

AbGn-168H

EXPERIMENTAL

AbGn-168H will be administered once weekly for four weeks via intravenous infusion.

Biological: AbGn-168H

Interventions

AbGn-168H BIOLOGICAL

Humanized monoclonal antibody

Also known as: Neihulizumab

AbGn-168H

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• AbGenomics B.V Taiwan Branch: lead

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

Study Officials

• Shih-Yao (David) Lin, MD, PhD

  AbGenomics B.V.

  STUDY DIRECTOR

• Everett Meyer, MD

  Stanford University Hospitals and Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: May 6, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 30, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)