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

Primary Purpose

Acute-graft-versus-host Disease, aGVHD, GVHD

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

EQ001

EQ001 Placebo

About this trial

This is an interventional treatment trial for Acute-graft-versus-host Disease

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

City of Hope Comprehensive Cancer Center
University of Florida Health Shands Hospital
University of Miami - Miller School of Medicine
H. Lee Moffitt Cancer Center & Research Institute
Emory University Hospital
Dana-Farber Cancer Institute
University of Michigan - C.S. Mott Children's Hospital
Washington University and Barnes Jewish Heart & Vascular Center
Roswell Park Cancer Institute
University of North Carolina Lineberger Comprehensive Cancer Center
Oregon Health & Science University
University of Pennsylvania, Abramson Cancer Center
University of Pittsburgh Cancer Institute
TriStar Centennial Medical Center (SCRI)
Intermountain Healthcare
Fred Hutchinson Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

EQ001 Dose Escalation (Part A)

EQ001 (Part B)

EQ001 Placebo (Part B)

Arm Description

Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses.

EQ001 administered in a blinded fashion using the optimal dose selected from Part A by intravenous infusion every two weeks for a total of 5 doses.

Placebo administered in a blinded fashion by intravenous infusion every two weeks for a total of 5 doses.

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Time to maximum EQ001serum concentration, Tmax

Time to maximum EQ001 serum concentration, Tmax

Maximum EQ001 serum drug concentration, Cmax

Minimum EQ001 serum drug concentration, Cmin

Minimum EQ001 serum drug concentration prior to next dose, Cmin

Total EQ001 exposure across time, AUC (from zero to infinity)

Half life of EQ001, t1/2

Volume of distribution of EQ001, Vd

Clearance, Cl

Inflammatory Markers

Including but not limited to: IL-1β, IL-2, IL-6, IL-17, IL-21, IL-22, IL-23, IFN-γ, and TGF-β, C-reactive protein

CD6 receptor expression levels

Full Information

NCT ID

NCT03763318

First Posted

November 19, 2018

Last Updated

March 7, 2023

Sponsor

Equillium

Collaborators

Biocon Limited

1. Study Identification

Unique Protocol Identification Number

NCT03763318

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

July 15, 2019 (Actual)

Primary Completion Date

November 21, 2022 (Actual)

Study Completion Date

November 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Equillium

Collaborators

Biocon Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute-graft-versus-host Disease, aGVHD, GVHD, GVHD, Acute

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Model Description

Part A is an open label 3+3 dose escalation Part B is blinded and randomized 2:1

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Part B will be blinded to all study staff that has direct access to the subjects and the sponsor. The site's pharmacist or designee will be unblinded to prepare the study drug.

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EQ001 Dose Escalation (Part A)

Arm Type

Experimental

Arm Description

Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses.

Arm Title

EQ001 (Part B)

Arm Type

Experimental

Arm Description

EQ001 administered in a blinded fashion using the optimal dose selected from Part A by intravenous infusion every two weeks for a total of 5 doses.

Arm Title

EQ001 Placebo (Part B)

Arm Type

Placebo Comparator

Arm Description

Placebo administered in a blinded fashion by intravenous infusion every two weeks for a total of 5 doses.

Intervention Type

Biological

Intervention Name(s)

EQ001

Other Intervention Name(s)

Bmab600, Itolizumab

Intervention Description

Itolizumab [Bmab 600])

Intervention Type

Biological

Intervention Name(s)

EQ001 Placebo

Intervention Description

EQ001 Placebo

Primary Outcome Measure Information:

Title

Incidence of Treatment Emergent Adverse Events

Description

Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Time Frame

Study Day 85

Title

Change from baseline in aGVHD organ stages and overall clinical grading, aGVHD-AI

Description

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

Time Frame

Study Day 337

Secondary Outcome Measure Information:

Title

Time to maximum EQ001serum concentration, Tmax

Description

Time to maximum EQ001 serum concentration, Tmax

Time Frame

Study Day 337

Title

Maximum EQ001 serum drug concentration, Cmax

Description

Maximum EQ001 serum drug concentration, Cmax

Time Frame

Study Day 337

Title

Minimum EQ001 serum drug concentration, Cmin

Description

Minimum EQ001 serum drug concentration prior to next dose, Cmin

Time Frame

Study Day 337

Title

Total EQ001 exposure across time, AUC (from zero to infinity)

Description

Total EQ001 exposure across time, AUC (from zero to infinity)

Time Frame

Study Day 337

Title

Half life of EQ001, t1/2

Description

Half life of EQ001, t1/2

Time Frame

Study Day 337

Title

Volume of distribution of EQ001, Vd

Description

Volume of distribution of EQ001, Vd

Time Frame

Study Day 337

Title

Clearance, Cl

Description

Clearance, Cl

Time Frame

Study Day 337

Title

Inflammatory Markers

Description

Including but not limited to: IL-1β, IL-2, IL-6, IL-17, IL-21, IL-22, IL-23, IFN-γ, and TGF-β, C-reactive protein

Time Frame

Study Day 337

Title

CD6 receptor expression levels

Description

CD6 receptor expression levels

Time Frame

Study Day 337

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel Rothman

Organizational Affiliation

Equillium

Official's Role

Study Director

Facility Information:

Facility Name

City of Hope Comprehensive Cancer Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

University of Florida Health Shands Hospital

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

University of Miami - Miller School of Medicine

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

H. Lee Moffitt Cancer Center & Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Emory University Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

University of Michigan - C.S. Mott Children's Hospital

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Washington University and Barnes Jewish Heart & Vascular Center

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Facility Name

University of North Carolina Lineberger Comprehensive Cancer Center

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

University of Pennsylvania, Abramson Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

University of Pittsburgh Cancer Institute

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

TriStar Centennial Medical Center (SCRI)

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

53719

Country

United States

Facility Name

Intermountain Healthcare

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84103

Country

United States

Facility Name

Fred Hutchinson Cancer Research Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109-4433

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35484649

Citation

Rambaldi B, Kim HT, Arihara Y, Asano T, Reynolds C, Manter M, Halpern M, Weber A, Koreth J, Cutler C, Gooptu M, Nikiforow S, Ho VT, Antin JH, Romee R, Ampudia J, Ng C, Connelly S, Soiffer RJ, Ritz J. Phenotypic and functional characterization of the CD6-ALCAM T-cell co-stimulatory pathway after allogeneic cell transplantation. Haematologica. 2022 Nov 1;107(11):2617-2629. doi: 10.3324/haematol.2021.280444.

Results Reference

derived

Links:

URL

https://equilliumbio.com

Description

Company website

Learn more about this trial

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

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