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Monoclonal Antibodies

Neihulizumab (ALTB-168) for Acute Graft-versus-Host Disease

Phase 1

Waitlist Available

Led By Paul Martin, MD

Research Sponsored by AltruBio Inc.

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 180

Awards & highlights

Study Summary

This trial is testing a new drug, Neihulizumab, to see if it is safe and effective in treating patients with a certain type of graft-versus-host disease that has not responded to other treatments.

Eligible Conditions

Acute Graft-versus-Host Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 180 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Pharmacokinetics of Neihulizumab - AUC

Pharmacokinetics of Neihulizumab - Cmax

Pharmacokinetics of Neihulizumab - Lambda-z

+4 more

Secondary outcome measures

Adverse Events (AEs)

Complete Response (CR)

Duration of Response

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Neihulizumab (ALTB-168)Experimental Treatment1 Intervention

Intravenous doses of Neihulizumab (ALTB-168)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neihulizumab (ALTB-168)

2018

Completed Phase 1

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AltruBio Inc.Lead Sponsor

3 Previous Clinical Trials

95 Total Patients Enrolled

Shih-Yao Lin, MD, PhDStudy DirectorAltruBio, Inc. (formerly AbGenomics International)

5 Previous Clinical Trials

111 Total Patients Enrolled

Paul Martin, MDPrincipal InvestigatorFred Hutchinson Cancer Center

Frequently Asked Questions

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

Does this trial represent a breakthrough in medical technology?

"Since 2018, Neihulizumab (AbGn-168H) has been subject to clinical trials sponsored by AltruBio Inc. The inaugural trial involved 37 patients and following successful Phase 1 drug approval, there are currently two active studies for the medication across 15 cities in one nation."

Answered by AI

Is there an open enrollment period for this research project at the present moment?

"Clinicaltrials.gov confirms that the search for suitable participants is still ongoing since its initial posting on May 31, 2018 and subsequent update on August 1st 2022."

Answered by AI

Have there been other experiments involving Neihulizumab (AbGn-168H) which have yielded meaningful results?

"Currently, two medical studies are underway that focus on Neihulizumab (AbGn-168H), and neither of them is in their terminal stage. These trials take place mainly around Milwaukee, Wisconsin but there are 16 different sites across the country where research for Neihulizumab (AbGn-168H) takes place."

Answered by AI

Has Neihulizumab (AbGn-168H) achieved regulatory authorization from the FDA?

"Since Neihulizumab (AbGn-168H) has only been through Phase 1 trials, which provide limited safety and efficacy data, our team at Power considers it a relatively low risk with a score of 1."

Answered by AI

What goals is this research attempting to achieve?

"The primary aim of this research, which will be evaluated over the course of up to 56 days, is determining neihulizumab-lambda's pharmacokinetics. Secondary objectives include evaluating adverse events as graded by CTCAE v4.03 and measuring overall response rate (ORR) at Day 28: CR+PR, along with assessing receptor occupancy via a flow cytometry based technique."

Answered by AI

What is the current enrollment size for this clinical research?

"Confirmative. Clinicaltrials.gov has logged that this experiment kicked off on May 31st 2018 and is presently recruiting individuals for participation. The trial requires 37 volunteers from a single location to move forward with the research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neihulizumab (ALTB-168) in Patients With Steroid-refractory Acute Graft-versus-host Disease or Treatment-refractory Acute Graft-versus-host Disease

2018. "Neihulizumab (ALTB-168) in Patients With Steroid-refractory Acute Graft-versus-host Disease or Treatment-refractory Acute Graft-versus-host Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03327857.