MedTrace Logo

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

NCT03327857 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2023-01-19

No results posted yet for this study

Summary

A Phase I study to establish the pharmacokinetics, pharmacodynamics, safety and efficacy profiles of Neihulizumab in patients with steroid-refractory or treatment refractory acute graft-versus-host disease (SR/TR-aGVHD)

Conditions

  • Steroid-refractory Acute Graft-versus-Host Disease
  • Treatment-refractory Acute Graft-versus-Host Disease

Interventions

BIOLOGICAL

Neihulizumab (ALTB-168)

Single dose phase: Patients will receive single dose of Neihulizumab based on the protocol escalation criteria. Multiple dose phase: Parients will receive weekly doses of Neihulizumab for 4 weeks.

Sponsors & Collaborators

  • AltruBio Inc.

    lead INDUSTRY

Principal Investigators

  • Shih-Yao Lin, MD, PhD · AltruBio, Inc. (formerly AbGenomics International)

  • Paul Martin, MD · Fred Hutchinson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2022-09-30
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03327857 on ClinicalTrials.gov