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Can tailored drug dosing make stem cell transplants safer?

NCT ID NCT07791576

Disease control Sponsor: Chinese PLA General Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether giving anti-thymocyte globulin (ATG) at a dose tailored to each patient's body can improve outcomes after a half-matched stem cell transplant. ATG is used to prevent graft-versus-host disease, a serious complication where donor cells attack the patient's body. Researchers will compare the standard dosing approach with a personalized one based on a pharmacokinetic formula. The main goal is to see if the tailored approach improves survival without severe graft-versus-host disease or relapse within the first year.

What this could mean

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

Active substance
Anti-thymocyte globulin (ATG), a drug that suppresses the immune system to prevent graft-versus-host disease, given at a dose tailored to each patient using a pharmacokinetic formula.
What this could lead to
If this works, it could reduce severe complications like graft-versus-host disease and relapse after stem cell transplants, improving survival and quality of life for patients with blood cancers.
What could go wrong
This is a Phase 2 trial with 63 participants, so results are preliminary. The personalized dosing may not improve outcomes, and ATG can increase infection risk, including viral reactivation.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 63 people

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

Started

May 2025

Expected to finish

Dec 2027

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

14 to 65 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 indications for allogeneic hematopoietic stem cell transplantation, with malignant hematologic diseases in CR1 or CR2 before transplantation. 2. Have an HLA-matched sibling, unrelated, or haploidentical donor. 3. Age ≥ 14 years and ≤ 65 years. 4. Liver function: ALT and AST ≤ 2.5 × upper limit of normal, bilirubin ≤ 2 × upper limit of normal. 5. Renal function: creatinine ≤ upper limit of normal. 6. No uncontrolled infection or severe mental or psychological disorders. 7. ECOG performance status score of 0-2. 8. Signed informed consent. Exclusion Criteria: 1. No HLA-matched donor. 2. Malignant hematologic disease in CR3 or higher disease stage, or refractory/relapsed status，or second transplantation. 3. Patient age \< 14 years or \> 65 years. 4. Pregnancy of either the donor or the recipient. 5. Presence of mental illness or other conditions that preclude compliance with the protocol.

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm

As listed by the trial registrant

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

Hematopoietic stem cell transplantation

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

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Contacts and locations

Locations

  • Chinese PLA General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100853, China

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