A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002)

Active:	No
Cancer Type:	Unknown Primary	NCT ID:	NCT04934670
Trial Phases:	Phase III	Protocol IDs:	BMT CTN 2002 (primary) NCI-2021-14060 2021-000343-53 5U24HL138660-02 XEN-TG-005
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Xenikos
NCI Full Details:	http://clinicaltrials.gov/show/NCT04934670

Summary

This is an open-label, randomized, Phase 3, multicenter trial, which has been designed to
compare the efficacy and safety of T-Guard to ruxolitinib in patients with Grade III or
IV Steroid-Refractory acute Graft-Versus-Host Disease (SR-aGVHD). The primary hypothesis
is that T-Guard treatment will improve the Day 28 complete response (CR) rate in patients
with Grades III and IV SR-aGVHD compared to ruxolitinib.

Objectives

Graft-vs-Host Disease (GVHD) is a complication that affects many hematopoietic stem cell
transplant (HSCT) patients; it occurs when the new cells from a transplant attack the
recipient's body. Acute GVHD (aGVHD) typically develops within the first three months
after HSCT and is typically treated with steroid therapy. A significant fraction of the
aGVHD population (10-50%) fail to respond to treatment and are deemed steroid-refractory
(SR).

Participants that develop Grade III or IV SR aGVHD will be randomized to receive T-Guard
or ruxolitinib and will be followed for approximately 180 days. Participants will be
stratified by center region (US vs. Europe) and age group (at least 55 years vs. under
55). Participants randomized to the T-Guard arm will receive 4 doses administered
intravenously as four 4-hour infusions, and participants randomized to the ruxolitinib
arm will receive one dose administered orally twice a day. The primary analysis will
include all participants that are randomized.

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