NCT02027805 is a Phase 1, PHASE2 clinical trial of T-Guard in Graft vs Host Disease, sponsored by Xenikos.

Who is sponsoring NCT02027805?

NCT02027805 is sponsored by Xenikos.

What drugs are being tested in NCT02027805?

Interventions in NCT02027805: T-Guard.

What condition does NCT02027805 study?

NCT02027805 studies Graft vs Host Disease.

Is NCT02027805 still recruiting?

NCT02027805 is currently completed. Last updated 6 June 2017.

Last reviewed 2017-06-06 · How we verify

NCT02027805

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1, PHASE2 Last updated 6 June 2017

What this trial tests

Phase 1, PHASE2 trial testing T-Guard in Graft vs Host Disease in 20 participants. Completed in 3 November 2016.

Timeline

5 March 2014

Primary endpoint
7 September 2016

3 November 2016

Quick facts

Lead sponsor	Xenikos
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	5 March 2014
Primary completion	7 September 2016
Estimated completion	3 November 2016
Sites	2 locations across Netherlands, Germany

Drugs / interventions tested

T-Guard — full drug profile →

Conditions studied

Graft vs Host Disease — all drugs for Graft vs Host Disease →

Sponsor

Xenikos — full company profile →

Who can join

18 and older, any sex, with Graft vs Host Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Phase I/II Trial of a Combination of Anti-CD3/CD7 Immunotoxins for Steroid-Refractory Acute Graft-versus-Host Disease.
Groth C, van Groningen LFJ, Matos TR, Bremmers ME, et al · · 2019 · cited 28× · PMID 30399420 · DOI 10.1016/j.bbmt.2018.10.020

Verify or expand the search:

Other trials of T-Guard

Trials testing the same drug.

NCT04934670 — A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002) · Phase 3 · terminated
NCT04128319 — T-Guard as Treatment for Steroid Refractory Acute GVHD (BMT CTN 1802) · Phase 3 · terminated

Other recruiting trials for Graft vs Host Disease

Currently open trials in the same condition.

NCT07184853 — Ruxolitinib Plus Etanercept vs Ruxolitinib for Steroid-Refractory Severe Acute GVHD · NA · recruiting
NCT06568328 — Chimeric Natural Killer Receptor-Universal T Cells for Refractory GVHD · Phase 1 · recruiting
NCT05531786 — Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) Af · Phase 1, PHASE2 · recruiting
NCT04044365 — Pediatric cGVHD Symptom Scale · recruiting
NCT02105766 — Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Bet · Phase 2 · active not recruiting

Other Xenikos trials

Trials by the same sponsor.

NCT04934670 — A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002) · Phase 3 · terminated
NCT04128319 — T-Guard as Treatment for Steroid Refractory Acute GVHD (BMT CTN 1802) · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02027805 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Xenikos
Last refreshed: 6 June 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02027805.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing