Acute Graft Versus Host DiseasePhase 1NCT02436460
A Study of AbGn-168H in Patients With Steroid Refractory Acute Graft-vs-Host Disease After Donor Stem Cell Transplant
A Phase 1 study testing AbGn-168H in people with Acute Graft Versus Host Disease, run by AbGenomics B.V Taiwan Branch at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Graft Versus Host Disease
- What is being tested?
- AbGn-168H
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase Ib Treatment Trial Using AbGn-168H to Treat Steroid Refractory Acute Graft-vs.-Host Disease (aGVHD) in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation
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.
Read the 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.
- Conditions
- Acute Graft Versus Host Disease
- Being tested
- AbGn-168H
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbGn-168HBiological
Also called Neihulizumab
Humanized monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| AbGn-168H | Experimental | AbGn-168H will be administered once weekly for four weeks via intravenous infusion. Receives: Biological: AbGn-168H |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Grade 3 to 5 adverse events considered at least possibly-related to neihulizumab
Measured: On or before study day 52
Cytokine release syndrome or acute infusion reactions
Grade 3 to 5 cytokine release syndrome or acute infusion reactions
Measured: Within 24 hours after study drug infusion
Neutropenia
Grade 4 neutropenia lasting more than 14 days considered at least possibly related to study drug
Measured: Duration of study
All-cause mortality
Grade 5 all-cause mortality
Measured: Within 7 days of infusion
Secondary outcomes (2)
Changes in frequency and/or phenotype of aGVHD-associated T-cell clones
Changes in T cell clonal dynamics will be accomplished by statistical methodology.
Measured: 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
Measured: At 90 days after the diagnosis of aGVHD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Re-initiate a new trial per the discussion with FDA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbGenomics B.V Taiwan Branch
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shih-Yao (David) Lin, MD, PhD, Study director, AbGenomics B.V.Everett Meyer, MD, Principal investigator, Stanford University Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436460
- Sponsor's protocol ID
- BMT 285
- Other IDs
- NCI-2015-00631, IRB-32842, 348, BMT 285
- Status last verified
- Mar 2017
- First submitted
- 1 May 2015
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Treatment Trial Using AbGn-168H to Treat Steroid Refractory Acute Graft-vs.-Host Disease (aGVHD) in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT02436460
- Acronym / sponsor ID
- BMT 285
- Conditions
- Acute Graft Versus Host Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Re-initiate a new trial per the discussion with FDA
- Enrolment
- 4 participants (actual)
- Lead sponsor
- AbGenomics B.V Taiwan BranchIndustry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AbGn-168H | Experimental | Biological: AbGn-168HAbGn-168H will be administered once weekly for four weeks via intravenous infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbGn-168HAlso: NeihulizumabHumanized monoclonal antibody | Biological | AbGn-168H |
Primary outcome
Adverse events
Time frame: On or before study day 52
Grade 3 to 5 adverse events considered at least possibly-related to neihulizumab
Cytokine release syndrome or acute infusion reactions
Time frame: Within 24 hours after study drug infusion
Grade 3 to 5 cytokine release syndrome or acute infusion reactions
Neutropenia
Time frame: Duration of study
Grade 4 neutropenia lasting more than 14 days considered at least possibly related to study drug
All-cause mortality
Time frame: Within 7 days of infusion
Grade 5 all-cause mortality
2 secondary outcomes
Changes in frequency and/or phenotype of aGVHD-associated T-cell clones
Time frame: At time of diagnosis up to 90 days
GVHD treatment response as measured by the Modified Keystone aGVHD clinical grade scale
Time frame: At 90 days after the diagnosis of aGVHD
Results and safety
The study was stopped early (reason given: Re-initiate a new trial per the discussion with FDA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shih-Yao (David) Lin, MD, PhD study director
AbGenomics B.V.
Everett Meyer, MD principal investigator
Stanford University Hospitals and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AbGn-168H in people with Acute Graft Versus Host Disease, run by AbGenomics B.V Taiwan Branch at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Re-initiate a new trial per the discussion with FDA). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: On or before study day 52). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.