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

GVHD Clinical Trial

— EQUATE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03763318
• Other study ID #: EQ001-aGVHD-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 15, 2019
• Est. completion date: November 21, 2022

Study information

• Verified date: March 2023
• Source: Equillium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Presence of morphologic relapsed primary malignancy, treatment for relapse after alloHSCT was performed, or requirement for rapid immunosuppressive treatment withdrawal for early malignancy relapse.

2. Evidence of graft failure based on cytopenia(s), and as determined by the investigator.

3. Evidence of post-transplant lymphoproliferative disease.

4. Any prior therapy for acute GVHD, except for alloHSCT prophylaxis regimens or systemically administered corticosteroids.

5. 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.

Related Conditions & MeSH terms

• Acute-graft-versus-host Disease
• aGVHD
• Graft vs Host Disease
• GVHD
• GVHD, Acute

Intervention

Biological:
• EQ001
Itolizumab [Bmab 600])
• EQ001 Placebo
EQ001 Placebo

Locations

Country	Name	City	State
United States	University of Michigan - C.S. Mott Children's Hospital	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	University of North Carolina Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	University of Florida Health Shands Hospital	Gainesville	Florida
United States	University of Miami - Miller School of Medicine	Miami	Florida
United States	TriStar Centennial Medical Center (SCRI)	Nashville	Tennessee
United States	University of Pennsylvania, Abramson Cancer Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Washington University and Barnes Jewish Heart & Vascular Center	Saint Louis	Missouri
United States	Intermountain Healthcare	Salt Lake City	Utah
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Equillium	Biocon Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Emergent Adverse Events	Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.	Study Day 85
Primary	Change from baseline in aGVHD organ stages and overall clinical grading, aGVHD-AI	Clinical activity will be assessed by change from baseline in aGVHD organ stages and overall clinical grading, aGVHD-AI, concomitant medication usage and disease progression assessments	Study Day 337
Secondary	Time to maximum EQ001serum concentration, Tmax	Time to maximum EQ001 serum concentration, Tmax	Study Day 337
Secondary	Maximum EQ001 serum drug concentration, Cmax	Maximum EQ001 serum drug concentration, Cmax	Study Day 337
Secondary	Minimum EQ001 serum drug concentration, Cmin	Minimum EQ001 serum drug concentration prior to next dose, Cmin	Study Day 337
Secondary	Total EQ001 exposure across time, AUC (from zero to infinity)	Total EQ001 exposure across time, AUC (from zero to infinity)	Study Day 337
Secondary	Half life of EQ001, t1/2	Half life of EQ001, t1/2	Study Day 337
Secondary	Volume of distribution of EQ001, Vd	Volume of distribution of EQ001, Vd	Study Day 337
Secondary	Clearance, Cl	Clearance, Cl	Study Day 337
Secondary	Inflammatory Markers	Including but not limited to: IL-1ß, IL-2, IL-6, IL-17, IL-21, IL-22, IL-23, IFN-?, and TGF-ß, C-reactive protein	Study Day 337
Secondary	CD6 receptor expression levels	CD6 receptor expression levels	Study Day 337

External Links

•   Company website