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Monoclonal Antibodies

Neihulizumab for Graft-versus-Host Disease

Phase 1

Recruiting

Led By Sameem Abedin, MD

Research Sponsored by Sameem M. Abedin, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients aged ≥ 18 years

Patients must have initial presentation of standard-risk aGVHD according to refined Minnesota Criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is to test a new drug, Neihulizumab, to see if it is safe and tolerated by patients with aGVHD.

Who is the study for?

Adults over 18 who've had an allogeneic transplant for standard-risk acute Graft Versus Host Disease (aGVHD) can join. They must not have used systemic immune suppressants for aGVHD yet, and women of childbearing age need to use two contraception methods or practice abstinence. Exclusions include uncontrolled infections, certain liver dysfunctions, severe health conditions like HIV or tuberculosis.Check my eligibility

What is being tested?

The trial is testing different doses of Neihulizumab to find the highest dose patients with aGVHD can tolerate without too many side effects. It's open to those who received any donor source and either myeloablative or non-myeloablative conditioning regimens before their transplant.See study design

What are the potential side effects?

Specific side effects are not listed here but generally could include reactions at the injection site, potential impact on organ function including liver and kidney issues, increased risk of infection due to immune system suppression, and possibly others as determined during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My first signs of graft-versus-host disease are considered standard-risk.

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I agree to use the specified methods of contraception.

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I have received a bone marrow transplant.

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I have received a transplant from any type of donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum-tolerated dose.

Secondary outcome measures

Non-relapse mortality.

Treatment response: Complete response

Treatment response: Partial response

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Neihulizumab Dose ExpansionExperimental Treatment1 Intervention

Upon determination of the maximum-tolerated dose, an expansion cohort of 4-7 patients will be enrolled so that a total of 10 patients are enrolled at the potential Phase II dose. This will be done to preliminarily assess efficacy.

Group II: Neihulizumab Dose Escalation, 9 mg/kgExperimental Treatment1 Intervention

Initial dose will be 6 mg weekly and the highest dose administered will be 9 mg weekly. Patients will be entered sequentially to each dose level. If 0 of the first 3 patients at that level has a DLT, new patients may be entered at the next higher dose level. If 1 of 3 patients has a DLT, up to 3 more patients are to be treated at that same dose level. If 0 of the additional 3 patients at that dose level has a DLT, new patients may be entered at the next higher dose level. If 1 or more of the additional 3 patients experience a DLT, 0 patients are to be started at that dose level and the preceding dose is the MTD. If 2 of 3 of the dosed patients has a DLT on the first dose level, the drug will be administered at a lower dose, 3 mg weekly. If 0 of 3 patients has a DLT at the highest dose level, an additional 3 patients will be enrolled to ensure that 6 patients are treated at the MTD. The MTD is the highest dose level at which no more than 1 of 6 treated patients, experiences a DLT.

Group III: Neihulizumab Dose Escalation, 6 mg/kgExperimental Treatment1 Intervention

Group IV: Neihulizumab Dose Escalation, 3 mg/kgExperimental Treatment1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sameem M. Abedin, MDLead Sponsor

1 Previous Clinical Trials

10,000 Total Patients Enrolled

Sameem Abedin, MDPrincipal InvestigatorMedical College of Wisconsin

4 Previous Clinical Trials

10,096 Total Patients Enrolled

Media Library

Neihulizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04144036 — Phase 1

Graft-versus-Host Disease Research Study Groups: Neihulizumab Dose Escalation, 3 mg/kg, Neihulizumab Dose Escalation, 6 mg/kg, Neihulizumab Dose Escalation, 9 mg/kg, Neihulizumab Dose Expansion

Graft-versus-Host Disease Clinical Trial 2023: Neihulizumab Highlights & Side Effects. Trial Name: NCT04144036 — Phase 1

Neihulizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04144036 — Phase 1

Frequently Asked Questions

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

What precedent exists for Neihulizumab in clinical research?

"Presently, there are two experiments involving Neihulizumab with none in the final phase. The trials for this medication largely take place within Milwaukee, WI, though it is possible to find a trial in one of 16 different locations across America."

Answered by AI

Is this experiment a pioneering endeavor?

"Neihulizumab has been studied since 2018 when AltruBio Inc. sponsored the first trial of 37 participants. After receiving Phase 1 drug approval in 2018, there are now two ongoing studies for Neihulizumab being conducted across 15 cities and one country."

Answered by AI

To what extent might Neihulizumab present a risk to patients?

"Neihulizumab received a safety score of 1 due to the paucity of evidence supporting its efficacy and minimal data regarding side effects, as it is currently in Phase 1."

Answered by AI

Is there an ongoing opportunity for individuals to become participants in this experiment?

"Going by the information found on clinicaltrials.gov, this particular medical trial is in search of participants. It was first posted on December 14th 2020 and has been updated as recently October 6th 2022."

Answered by AI

How many individuals are being recruited to participate in this research?

"Affirmative. According to the information made available on clinicaltrials.gov, this trial is currently recruiting participants. It was first posted on December 14th 2020 and last updated by October 6th 2022; 16 individuals are being sought for enrolment at one site in particular."

Answered by AI

What goals is this clinical trial attempting to accomplish?

"The primary outcome of this experiment, to be assessed after a 28-day period, will be the Maximum-tolerated dose. Secondary outcomes include Partial response (GVHD that improves by at least one stage without worsening elsewhere), Non-relapse mortality (deaths not caused by relapse) and Complete response (complete GVHD resolution). Assessments for Acute GVHD will follow the Mount Sinai Acute GVHD International Consortium's MAGIC algorithm."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neihulizumab for Standard-Risk Acute Graft Versus Host Disease (GVHD)

Sameem M. Abedin, MD 2020. "Neihulizumab for Standard-Risk Acute Graft Versus Host Disease (GVHD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04144036.

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