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A Phase 1b / 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of EQ001 in Subjects With Newly Diagnosed Acute Graft Versus Host Disease

Status
Active
Cancer Type
Bone and Soft Tissue (including Sarcoma)
Trial Phase
Phase I
Phase II
Eligibility
12 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03763318
Protocol IDs
EQ001-aGVHD-001 (primary)
NCI-2019-01124
Study Sponsor
Equillium

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 84 subjects in two (2) parts: Part A is an open label study and will enroll approximately 24 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.
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