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Safety and Efficacy Study of T-Guard to Treat Steroid-resistant Acute GVHD

NCT02027805 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-06-06

No results posted yet for this study

Summary

In this study, a combination of two antibodies both conjugated to a cell-killing toxin (so-called immunotoxins) will be evaluated. The antibodies are directed against T-cell antigens 'cluster of differentiation 3 antigen' (CD3) and CD7. Previous in vitro studies have demonstrated that this particular immunotoxin-combination, named T-Guard, acts synergistically in eliminating T cells with a preference for killing activated T-cells. In a subsequent clinical pilot-study, T-Guard has generated encouraging results when applied as third-line therapy for patients suffering form steroid-resistant acute Graft-versus-Host Disease (GVHD). Extensive biological and clinical responses could be noted in the absence of severe acute toxicities. Building on these results, the current study aims at evaluating the safety and efficacy of T-Guard for treating steroid-resistant GVHD when administered in an earlier phase of the disease process, i.e. as second-line instead of as third-line therapy.

Conditions

  • Graft vs Host Disease

Interventions

BIOLOGICAL

T-Guard

Sponsors & Collaborators

  • Xenikos

    lead INDUSTRY

Principal Investigators

  • Walter Van der Velden, MD, PhD · Radboudumc, Nijmegen (Netherlands)

  • Matthias Stelljes, MD, PhD · Unversity Hospital Münster, Münster (Germany)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-05
Primary Completion
2016-09-07
Completion
2016-11-03

Countries

  • Germany
  • Netherlands

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 NCT02027805 on ClinicalTrials.gov