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

NCT04144036 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-10-01

No results posted yet for this study

Summary

This is a single-center Phase I study to determine the maximum tolerated dose and safety of Neihulizumab for the treatment of Minnesota standard-risk aGVHD. Patients undergoing allogeneic transplant with either a myeloablative or non-myeloablative conditioning regimen, and recipients of all donor sources will be enrolled to this trial.

Conditions

  • Graft-versus-host Disease

Interventions

BIOLOGICAL

Neihulizumab, 3 mg/kg

The doses for the 3 + 3 design (dose escalation phase) are listed in the arm description. The dose-expansion phase will use the maximum-tolerated dose.

DRUG

Neihulizumab, 6 mg/kg

The doses for the 3 + 3 design (dose escalation phase) are listed in the arm description. The dose-expansion phase will use the maximum-tolerated dose.

DRUG

Neihulizumab, 9 mg/kg

The doses for the 3 + 3 design (dose escalation phase) are listed in the arm description. The dose-expansion phase will use the maximum-tolerated dose.

DRUG

Neihulizumab

This arm will receive the Maximum Tolerated Dose determined in the Drug Escalation phase.

Sponsors & Collaborators

  • Sameem M. Abedin, MD

    lead OTHER

Principal Investigators

  • Sameem Abedin, MD · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2023-04-20
Completion
2024-07-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04144036 on ClinicalTrials.gov