CLINICAL TRIAL

Neihulizumab (AbGn-168H) for Graft vs Host Disease

Refractory
Recruiting · Any Age · All Sexes · Atlanta, GA

This study is evaluating whether a drug may help treat a type of graft-versus-host disease.

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About the trial for Graft vs Host Disease

Eligible Conditions
Steroid Refractory Acute Graft Versus Host Disease · Graft vs Host Disease · Treatment-refractory Acute Graft-versus-Host Disease

Treatment Groups

This trial involves 2 different treatments. Neihulizumab (AbGn-168H) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Neihulizumab (AbGn-168H)
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex of any age. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
progressed after 3 days of treatment with methylprednisolone (MP) 2 mg/kg/day equivalent, or did not improve after 7 days of treatment with MP 2 mg/kg/day equivalent, or progressed to involve a new organ after treatment with MP 1 mg/kg/day equivalent for skin and upper gastrointestinal (GI) GVHD, or recurred during or after a steroid taper
For single dose phase: Patients must have erythematous manifestations of cutaneous aGVHD. Characteristics of the rash must indicate active inflammation (red coloration) as distinct from resolving inflammation (brown coloration).
Females of childbearing potential must have a negative pregnancy test result before enrollment. Males and females of childbearing potential must agree to use a highly effective method of birth control during the study for at least 30 days after enrollment in the study.
Patients must have clinical aGVHD and pathologic findings consistent with the diagnosis by biopsy of at least 1 involved site,
For single dose phase: Providers and patients must be willing to defer new systemic or cutaneous topical treatment of aGVHD for at least 36 hr after administration of Neihulizumab.
Patient must give informed consent and sign an approved consent form prior to any study procedures.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 180
Screening: ~3 weeks
Treatment: Varies
Reporting: Day 180
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 180.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Neihulizumab (AbGn-168H) will improve 7 primary outcomes and 8 secondary outcomes in patients with Graft vs Host Disease. Measurement will happen over the course of Day 28.

Complete Response (CR)
DAY 28
To assess the rate of complete response (CR) at Day 28 in patients treated with Neihulizumab
DAY 28
Overall Response Rate (ORR)
DAY 28
To assess the Overall Response Rate (ORR) at Day 28: CR+PR
DAY 28
Immunogenicity
UP TO DAY 56
Immunogenicity will be monitored by anti-drug antibody (ADA) ELISA
UP TO DAY 56
Pharmacokinetics of Neihulizumab - MRT
UP TO DAY 56
Mean Residence Time
UP TO DAY 56
Pharmacokinetics of Neihulizumab - tmax
UP TO DAY 56
Time to reach Cmax
UP TO DAY 56
Pharmacokinetics of Neihulizumab - t1/2
UP TO DAY 56
Half life
UP TO DAY 56
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for graft vs host disease?

The recommended treatments for GVHD include: prophylactic treatment with corticosteroids, antilymphocyte globulin, cyclosporine, tacrolimus (FK506, Prograf), azathioprine, MMF, and mycophenolate mofetil. All of these medications have been shown to provide remission to a majority of patients with GVHD.

Anonymous Patient Answer

What is graft vs host disease?

Graft vs host disease occurs when an allogeneic bone marrow transplant fails to confer protective effect against the recipient's immune attack; it results in various clinical manifestations of the disease, including life-threatening complications (secondary) which require specific treatment. The most important signs are skin lesions and oral and gastrointestinal dysfunction. The immunological mechanism involved with GvHD and the cellular elements of the immune machinery responsible for its development have to be further elucidated. Currently the focus of clinicians' attention has to be on alloreactivity and on the regulation of an adaptive immune response in order to be able to prevent or delay allograft rejection.

Anonymous Patient Answer

How many people get graft vs host disease a year in the United States?

Around 10 million people will develop it. Many people become disoriented, lose weight, have difficulty in school, and may end up not seeing a doctor until it has got serious.

Anonymous Patient Answer

Can graft vs host disease be cured?

With a relatively poor prognosis after allogeneic stem cell transplantation (ASCT), the use of T cells to prevent graft vs host disease should be considered in carefully selected cases.

Anonymous Patient Answer

What are the signs of graft vs host disease?

Chronic illness of the gut and/or liver and a positive CBC and/or CRP may indicate a manifestation of GVHD. CXR alone or in combination with CT scans can assist in deciding what treatment to employ.

Anonymous Patient Answer

What causes graft vs host disease?

Graft-vs-host disease (GvHD) is the result of the transplantation of T-lymphocytes from a genetically-similar or identical donor into a genetically-distinct host. GvHD is the third most common cause of transplant rejection after the transplantation of T-lymphocytes and the rejection of allograft bone marrow. A more aggressive treatment regimen reduces the overall incidence and severity of GvHD. The incidence of GvHD depends on the age of the recipient, the type of allograft transplanted, the conditioning regimen used preceding transplantation, the overall health of the recipient following the transplantation, and the genetic diversity of the organ donor and recipient.

Anonymous Patient Answer

Who should consider clinical trials for graft vs host disease?

GVHD is a serious disease with devastating effects on quality of life. There are no reliable clinical markers for its development and treatment depends on symptoms, severity of disease and overall health status. In many patients with the disorder systemic treatment is indicated, particularly corticosteroids, cyclosporin and mycophenolate mofetil. However, only few patients require these agents. We consider the presence of positive progesterone markers or in women also of male origin to be predictive of the development of GVHD. We therefore strongly encourage clinical trials that involve GVHD.

Anonymous Patient Answer

Does graft vs host disease run in families?

The GvHD phenotype run in family. The clinical features in this large multiethnic study are consistent with those previously reported. The GvHD phenotype appears to be similar to other forms of AIE presenting in similar ways at different ages and in diverse geographic geographical loci and may represent a novel class of autoinflammatory diseases.

Anonymous Patient Answer

Is neihulizumab (abgn-168h) typically used in combination with any other treatments?

Neihulizumab can be used in combination with radiation therapy to treat metastatic or locally advanced non-[small cell lung cancer](https://www.withpower.com/clinical-trials/small-cell-lung-cancer) as well as pancreatic cancer. Neihulizumab can also be used together with chemotherapy to treat non- small cell lung cancer. Neihulizumab plus chemotherapy can also be effective in treating renal cell carcinoma. Neihulizumab plus chemotherapy is less frequently used to treat small cell lung carcinoma.

Anonymous Patient Answer

How serious can graft vs host disease be?

In solid organ transplantation the condition of the patient and the type of donor are of great importance. However, because one-fourth of all patients who receive bone marrow transplants develop GvHD, the seriousness of this disease can vary from mild to severe and has even caused death. GvHD can be divided into four grades of severity: 0 to I. Considering the severity, grade II (mild) GvHD is usually manageable and, in the majority of cases, the patient can be treated and go on living life normally. In grade III (moderate) GvHD is the most troublesome. In these patients there are often many chronic diseases.

Anonymous Patient Answer

What are the common side effects of neihulizumab (abgn-168h)?

In this multicenter, prospective study, the main observed side effects of abgn-168h were headache, nausea, diarrhea, and vomiting. There was a greater incidence of headache and nausea compared with placebo and abgn-168h, which showed promising efficacy and tolerability. Diarrhea was common in all patients regardless of treatment and was most prevalent in healthy adult male patients receiving abgn-168h at the higher dose. Data from a recent study was not designed to exclude the possibility of a drug-drug interaction in patients receiving abgn-168h with a concomitant treatment with oral contraceptives or other medications with the potential to prolong intestinal transit time.

Anonymous Patient Answer

What is the average age someone gets graft vs host disease?

G-GVHD has a mean age of onset at 10.6 years old. It occurs predominantly in adult males with an HLA-B13:Ile()150 homozygous genotype that is associated with an increased risk of GVHD. The pathophysiological underlying factors for this predisposition are not clear. It is evident that there is considerable variation in age of patients with GVHD. In the large GVHD registry of Canada we observed an overall median age of onset of 4.9 years, with a range of 6 months and 16 years of age. In the current clinical setting, the age of GVHD patients is reported to be around 10–12 years.

Anonymous Patient Answer
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