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

NCT03763318 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: EQ001-aGVHD-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 16

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Number 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

• Overall Response Rate

  Overall Response Rate (ORR) is defined as the number of subjects with a partial response (PR), very good partial response (VGPR), or complete response (CR) who are alive at Day 29. Subjects must not have received new systemic therapy for aGVHD before the Day 29 Visit.

  Study Day 29

Secondary Outcomes (9)

• Time to Maximum EQ001serum Concentration, Tmax

  Day 337

• Maximum EQ001 Serum Drug Concentration, Cmax

  Study Day 337

• Minimum EQ001 Serum Drug Concentration, Cmin

  Study Day 337

• Total EQ001 Exposure Across Time, AUC (From Zero to Infinity)

  Study Day 337

• Half Life of EQ001, t1/2

  Study Day 337

Study Arms (3)

EQ001 Dose Escalation (Part A)

EXPERIMENTAL

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

Biological: EQ001

EQ001 (Part B)

EXPERIMENTAL

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.

Biological: EQ001

EQ001 Placebo (Part B)

PLACEBO COMPARATOR

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

Biological: EQ001 Placebo

Interventions

EQ001 BIOLOGICAL

Itolizumab \[Bmab 600\])

Also known as: Bmab600, Itolizumab

EQ001 (Part B); EQ001 Dose Escalation (Part A)

EQ001 Placebo BIOLOGICAL

EQ001 Placebo

EQ001 Placebo (Part B)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Equillium: lead
• Biocon Limited: collaborator

Study Sites (16)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

University of Florida Health Shands Hospital

Gainesville, Florida, 32610, United States

Location

University of Miami - Miller School of Medicine

Miami, Florida, 33136, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

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

Ann Arbor, Michigan, 48109, United States

Location

Washington University and Barnes Jewish Heart & Vascular Center

St Louis, Missouri, 63110, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

TriStar Centennial Medical Center (SCRI)

Nashville, Tennessee, 53719, United States

Location

Intermountain Healthcare

Salt Lake City, Utah, 84103, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-4433, United States

Location

Related Publications (1)

• 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.

  PMID: 35484649 DERIVED

Related Links

• Company website

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

itolizumab

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Clinical Operations
• Organization: Equillium

clinicaltrials@equilliumbio.com

858-240-1200

Study Officials

• Joel Rothman

  Equillium

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: December 4, 2018
• Study Start: July 15, 2019
• Primary Completion: November 21, 2022
• Study Completion: November 21, 2022
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)