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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Acute-graft-versus-host Disease, aGVHD, GVHD, GVHD, Acute

In brief

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).

Key facts

Study ID

NCT03763318

Run by

Biocon Limited

People needed

30

Starts

2019-07-15

Expected to finish

2022-11-21

Last updated by the study team

2026-06-11

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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