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New antibody may offer safer shield against transplant complications

NCT ID NCT07689630

Disease control Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This phase 3 trial compares an anti-CD25 monoclonal antibody (daclizumab) with methotrexate for preventing acute graft-versus-host disease (GVHD) in people with blood cancers receiving a half-matched stem cell transplant. GVHD is a serious complication where donor immune cells attack the patient's body. The study aims to see if the antibody can reduce GVHD and side effects like mouth sores and slow blood recovery. Participants are randomly assigned to receive either the antibody or methotrexate, along with standard GVHD prevention drugs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Anti-CD25 monoclonal antibody (daclizumab)
What this could lead to
If successful, this could offer a safer way to prevent graft-versus-host disease after stem cell transplants, reducing side effects like mouth sores and slow blood recovery.
What could go wrong
This is an early-phase trial with 186 participants, so results may not apply to all patients. The anti-CD25 antibody could still cause infections or other complications.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 186 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 75 years

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. Patients with confirmed hematologic malignancies who are scheduled to undergo haploidentical allogeneic hematopoietic stem cell transplantation. 2. Age 18 to 75 years. 3. Willing to provide written informed consent and accept random assignment. 4. Willing and able to comply with the study procedures throughout the study period. Exclusion Criteria: 1. Patients scheduled to undergo fully matched donor transplantation, unrelated donor transplantation, or umbilical cord blood transplantation. 2. Patients receiving grafts from maternal donors or collateral relative donors. 3. Patients with strongly positive donor-specific antibodies. 4. Patients whose transplantation regimen includes post-transplant cyclophosphamide for graft-versus-host disease prophylaxis. 5. Patients undergoing a second transplantation. 6. Patients who refuse to provide written informed consent.

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Conditions

The condition(s) this trial relates to.

graft versus host disease hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm acute graft versus host disease prevention target

As listed by the trial registrant

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

Graft -versus-host-disease Hematologic neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430022, China

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