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
Bone and Soft Tissue (including Sarcoma)
12 Years and older, Male and Female
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).
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.