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

Status
Completed
Cancer Type
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
12 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03763318
Protocol IDs
EQ001-aGVHD-001 (primary)
NCI-2019-01124
Study Sponsor
Equillium Inc

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.

Eligibility

  1. Male or female subject at least 18 years of age for Part A, and at least 12 years of age for Part B.
  2. Recipients of allogeneic hematopoietic stem cell transplantation (alloHSCT) using myeloablative or non myeloablative conditioning regimens.
  3. Have a clinical diagnosis of acute GVHD requiring systemic immune suppressive therapy.
  4. Deemed by the investigator to be likely to comply with the planned procedure as required by the protocol for the duration of the study

Treatment Sites in Georgia

Emory University Hospital - Atlanta


1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.