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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    100
  • sponsor
    Equillium
Updated on 9 February 2022
cell transplantation
myeloablative conditioning
acute graft-versus-host disease
allogeneic hematopoietic stem cell transplant

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).

Description

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.

Details
Condition Acute-graft-versus-host Disease, aGVHD, GVHD, GVHD, Acute
Treatment EQ001, EQ001 Placebo
Clinical Study IdentifierNCT03763318
SponsorEquillium
Last Modified on9 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Presence of morphologic relapsed primary malignancy, treatment for relapse after alloHSCT was performed, or requirement for rapid immunosuppressive treatment withdrawal for early malignancy relapse
Evidence of graft failure based on cytopenia(s), and as determined by the investigator
Evidence of post-transplant lymphoproliferative disease
Any prior therapy for acute GVHD, except for alloHSCT prophylaxis regimens or systemically administered corticosteroids
As determined by the investigator, any medical, psychiatric, or other condition or circumstance that is likely to negatively affect: the subject's participation in this clinical study, the subject's safety, or the reliability of the study data
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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