A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD
NCT ID: NCT03763318
Last Updated: 2025-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2019-07-15
2022-11-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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EQ001 Dose Escalation (Part A)
Open label EQ001 administered by intravenous infusion every two weeks for a total of 5 doses.
EQ001
Itolizumab \[Bmab 600\])
EQ001 (Part B)
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.
EQ001
Itolizumab \[Bmab 600\])
EQ001 Placebo (Part B)
Placebo administered in a blinded fashion by intravenous infusion every two weeks for a total of 5 doses.
EQ001 Placebo
EQ001 Placebo
Interventions
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EQ001
Itolizumab \[Bmab 600\])
EQ001 Placebo
EQ001 Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
ALL
No
Sponsors
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Biocon Limited
INDUSTRY
Equillium
INDUSTRY
Responsible Party
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Principal Investigators
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Joel Rothman
Role: STUDY_DIRECTOR
Equillium
Locations
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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
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan - C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
Washington University and Barnes Jewish Heart & Vascular Center
St Louis, Missouri, 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
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
TriStar Centennial Medical Center (SCRI)
Nashville, Tennessee, United States
Intermountain Healthcare
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Company website
Other Identifiers
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EQ001-aGVHD-001
Identifier Type: -
Identifier Source: org_study_id
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