A Study of AbGn-168H in Patients With Steroid Refractory... | NCT02436460

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

NCT02436460

Sponsor

AbGenomics B.V Taiwan Branch

Status

Terminated

Last Update Posted

Mar 30, 2017Actual

Enrollment

4Actual

Phase

Phase 1

Conditions

Acute Graft Versus Host Disease

Interventions

AbGn-168H

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
NCI-2015-00631	Registry Identifier	CTRP (Clinical Trial Reporting Program)
IRB-32842
348
BMT 285	Other Identifier	Stanford University Hospitals and Clinics

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Re-initiate a new trial per the discussion with FDA

Expanded Access Info

Start Date

May 2015Actual

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

May 1, 2015

First Submission Date that Met QC Criteria

May 1, 2015

First Posted Date

May 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2017

Last Update Posted Date

Mar 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AbGn-168H	Experimental	AbGn-168H will be administered once weekly for four weeks via intravenous infusion.	Biological: AbGn-168H

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AbGn-168H	Biological	Humanized monoclonal antibody	AbGn-168H	Neihulizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Changes in frequency and/or phenotype of aGVHD-associated T-cell clones	Changes in T cell clonal dynamics will be accomplished by statistical methodology.	At time of diagnosis up to 90 days
GVHD treatment response as measured by the Modified Keystone aGVHD clinical grade scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shih-Yao (David) Lin, MD, PhD	AbGenomics B.V.	Study Director
Everett Meyer, MD	Stanford University Hospitals and Clinics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University, School of Medicine		Stanford	California	94305	United States