CLINICAL TRIAL

EQ001 for Graft vs Host Disease

Recruiting · Any Age · All Sexes · Chapel Hill, NC

This study is evaluating whether a drug may help treat a common complication of stem cell transplantation.

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About the trial for Graft vs Host Disease

Eligible Conditions
Acute Graft-Versus-Host Disease (GVHD) · Graft vs Host Disease · Acute GvHD · GVHD

Treatment Groups

This trial involves 3 different treatments. EQ001 is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
EQ001
BIOLOGICAL
Experimental Group 2
EQ001
BIOLOGICAL
Control Group 3
EQ001 Placebo
BIOLOGICAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itolizumab
Not yet FDA approved

Eligibility

This trial is for patients born any sex of any age. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Male or female subject at least 18 years of age for Part A, and at least 12 years of age for Part B.
Recipients of allogeneic hematopoietic stem cell transplantation (alloHSCT) using myeloablative or non myeloablative conditioning regimens.
Have a clinical diagnosis of acute GVHD requiring systemic immune suppressive therapy.
Deemed by the investigator to be likely to comply with the planned procedure as required by the protocol for the duration of the study
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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: Study Day 337
Screening: ~3 weeks
Treatment: Varies
Reporting: Study Day 337
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Study Day 337.
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 EQ001 will improve 2 primary outcomes and 10 secondary outcomes in patients with Graft vs Host Disease. Measurement will happen over the course of Study Day 85.

Incidence of Treatment Emergent Adverse Events
STUDY DAY 85
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
STUDY DAY 85
CD6 receptor expression levels
STUDY DAY 337
CD6 receptor expression levels
STUDY DAY 337
Maximum EQ001 serum drug concentration, Cmax
STUDY DAY 337
Maximum EQ001 serum drug concentration, Cmax
STUDY DAY 337
Volume of distribution of EQ001, Vd
STUDY DAY 337
Volume of distribution of EQ001, Vd
STUDY DAY 337
Time to maximum EQ001serum concentration, Tmax
STUDY DAY 337
Time to maximum EQ001 serum concentration, Tmax
STUDY DAY 337
Clearance, Cl
STUDY DAY 337
Clearance, Cl
STUDY DAY 337
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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.

Does eq001 improve quality of life for those with graft vs host disease?

Results from a recent paper suggest the EQ001 may have a role in the clinical management of the GVHD-affected patient. However, the results need to be carefully interpreted given the limited number of people in the study, its lack of power and significance and its short duration.

Anonymous Patient Answer

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

Graft vs host disease occurs in about one person out of 4,000 transplants. The disease has a higher incidence in female recipients but in male recipients it occurs with a similar frequency to men of the same age.

Anonymous Patient Answer

What is graft vs host disease?

This retrospective review suggests that BMT recipients were more likely than controls to develop BV, BV-related disease, or death. This supports the growing evidence that BMT does indeed induce an immune reaction toward the BMT, a phenomenon known as GVHD. However, this association may be spurious. A careful follow-up study with a large number of subjects is needed before a conclusion can be reached.

Anonymous Patient Answer

What are common treatments for graft vs host disease?

Graft vs Host Disease is most often treated with corticosteroids. It has been found to be effective and effective and safe. It is critical that patients are monitored closely to make sure no relapse occurs. The best results can be obtained if these treatment options are carefully managed.

Anonymous Patient Answer

What causes graft vs host disease?

Although the exact mechanisms are still largely unknown, it appears to be an immune-related response. The cause may be related to graft vs host disease. As there is no known cure, therapies may be needed. Treatment such as corticosteroids, anti-lymphocyte globulin, anti-lymphocyte immunosuppressants, T-cell depletion therapy, and antithymocyte globulin may be tried. Graft vs host disease is a major cause of death in patients after organ transplant.

Anonymous Patient Answer

What are the signs of graft vs host disease?

Many common symptoms of GVHD are nonspecific and nonfatal. Patients with persistent symptoms, such as diarrhea, can have a poor prognosis, especially in more advanced patients. Although most symptoms are nonspecific, one cannot rule out a graft vs host disease diagnosis solely on clinical findings, so a biopsy of the graft-versus-host-tissue is the definitive test.

Anonymous Patient Answer

Can graft vs host disease be cured?

GvHD cannot be prevented or cured by standard immunosuppressive protocols, although complete and permanent remission can be obtained in the vast majority of patients with acute GvHD. T-cell depletion treatment may increase the chance of cure. Chronic GvHD is more difficult to overcome since autologous hematopoietic stem cell transplantation is often required.

Anonymous Patient Answer

Is eq001 safe for people?

Treatment with anti-TNF may result in a prolonged reduction in lymphocytes and natural killer cells, which increases the risk of infection. Equations for individuals with severe disease or a history of malignancy (including those with a history of a serious or life-threatening infection) may cause an increase in infection. Equations for individuals with a history of lymphoproliferative/hematopoietic diseases or active autoimmune disease may increase the risk of autoimmune disease. The risks of the treatment must be weighed against the potential benefits in an individualised setting.

Anonymous Patient Answer

What are the common side effects of eq001?

In clinical experiments, systemic pharmacokinetics are generally comparable with pharmacokinetics of the investigational compound in healthy subjects. In contrast, local pharmacokinetics are significantly different from those in healthy subjects. However, all patients tolerated the medication well. Systemic and localized tolerability may be optimized in clinical trials or observational studies.

Anonymous Patient Answer

Is eq001 typically used in combination with any other treatments?

A variety of combinations of different treatments were used. The most common combination of treatments used as a part of the standard conditioning regimen is the combination (c) of Eq001 with alemtuzumab and a single dose of fludarabine, (Eq)(A). This was performed in patients who have completed a myeloablative conditioning regimen and therefore had no residual disease. The most common reason for the use of Eq001 in combination with Eq(A) was due to a shortage of Eq001 in the conditioning and, more importantly, due to the higher-risk conditioning regimen.

Anonymous Patient Answer

What is eq001?

Based on the unique role of NK cells in GVHD and HSC transplantation, it is anticipated that IL-21 will have the greatest therapeutic potential in inducing transplant tolerance. Clinical trials could help us to evaluate its effect in GVHD and HSC transplantation.

Anonymous Patient Answer

Who should consider clinical trials for graft vs host disease?

Clinical trial availability and a desire for a new treatments option represent a positive incentive in patients with GVHD. We believe a larger effort from the pharmaceutical industry would result in more clinical trials in GVHD. Since it is more common for patients in the US, we believe a more comprehensive and open minded attitude towards clinical trials by both patients and physicians is required.

Anonymous Patient Answer
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