A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD

Active:	No
Cancer Type:	Unknown Primary	NCT ID:	NCT03763318
Trial Phases:	Phase I Phase II	Protocol IDs:	EQ001-aGVHD-001 (primary) NCI-2019-01124
Eligibility:	12 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Equillium Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT03763318

Summary

This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical
activity of EQ001 in subjects with Acute Graft Versus Host Disease (aGVHD).

Objectives

The study will enroll approximately 100 subjects in two (2) parts:

Part A is an open label study and will enroll approximately 40 evaluable subjects with aGVHD
across 4 cohorts. The total number of patients will depend on the number of dose escalations
necessary to enable a decision to be made on the recommended dose to take forward into Part B
of the study. The planned dose escalation will start with cohort 1, where subjects will
receive EQ001 administered intravenously every two weeks for a total of 5 doses.

Part B is a randomized, double-blind, placebo-controlled study and will enroll approximately
60 additional subjects, randomized in a 2:1 ratio to either active treatment EQ001 (40) or
placebo (20). Subjects will receive either EQ001 or placebo administered intravenously every
two weeks for a total of 5 doses.

Treatment Sites in Georgia

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

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