IRB #

STUDY00019856

Title

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

Principal Investigator

Gabrielle Meyers

Study Purpose

The purpose of the study is to test the safety of EQ001 (study drug) at different dose levels (amounts) when given as an infusion. We want to find out what effects, good and/or bad, EQ001 has on you and your acute GVHD. We also want to measure levels of EQ001 in your blood. Your voluntary participation in this research study may help to determine whether EQ001 is safe when given to participants with acute GVHD like yours.

Medical Condition(s)

Newly diagosed acute graft versus host disease (aGvHD)

Eligibility Criteria

- 18 years or older
- Recipients of first allogeneic hematopoietic stem cell transplantation using myeloablative or non-myeloablative conditioning regimens
- Clinical diagnosis of acute GVHD requiring systemic immune suppressive therapy
- No relapse of primary malignancy or treatment for relapse after allo transplant
- No prior therapy for acute GVHD
- No severe organ dysfunction

Age Range

18 - 110

Healthy Volunteers Needed

No

Duration of Participation

Your participation in the study will consist of 16 visits over about 1 year (Study Day 337). Visits will last up to 6 hours.

Minors Included

No

Contact

Knight Cancer Intake Center: (503)494-7999
Clinical Trials Information Line: (503)­494-­1080 or trials@ohsu.edu

Sponsor

Equillium

Recruitment End

01/01/2025

Compensation Provided

No


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