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New drug shows promise in controlling transplant complications

NCT ID NCT03763318

Disease control Sponsor: Biocon Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called EQ001 in 30 people who developed acute graft-versus-host disease (aGVHD) after a stem cell transplant. aGVHD is a serious condition where donor immune cells attack the patient's body. The goal was to see if EQ001 is safe and can help control this immune reaction. Participants received the drug and were monitored for side effects and treatment response.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

30 people

The number who actually took part.

Started

Jul 2019

Finished

Nov 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute-graft-versus-host disease AGVHD GVHD GVHD, acute

Contacts and locations

Locations

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-4433, United States

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612, United States

  • Intermountain Healthcare

    Salt Lake City, Utah, 84103, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • TriStar Centennial Medical Center (SCRI)

    Nashville, Tennessee, 53719, United States

  • University of Florida Health Shands Hospital

    Gainesville, Florida, 32610, United States

  • University of Miami - Miller School of Medicine

    Miami, Florida, 33136, United States

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

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania, Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232, United States

  • Washington University and Barnes Jewish Heart & Vascular Center

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.