Can a different immune drug cut viral infections after stem cell transplants?

NCT ID NCT06895538

Disease control Sponsor: Peking University First Hospital Source: ClinicalTrials.gov ↗

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests whether a drug called ATLG, used before a stem cell transplant, can help the immune system recover better and reduce viral infections compared to the standard drug ATG. The study involves adults with blood cancers like leukemia, lymphoma, or MDS who are receiving their first transplant. Participants will get either ATLG or ATG as part of their conditioning regimen, and researchers will track immune recovery and infection rates afterward.

What this could mean

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

Active substance: Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG)
What this could lead to: If ATLG works better than the standard ATG, it could lower the risk of serious viral infections and improve immune recovery after stem cell transplants, making the procedure safer for people with blood cancers.
What could go wrong: This is an early-stage, small study (24 participants) and not randomized, so results may not be conclusive. ATLG may not prove superior to ATG, and both drugs carry risks like increased infection or immune complications.

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Study facts

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

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 24 people

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

Started

May 2025

Expected to finish

Feb 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

18 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）Age ≧18 years, gender is not limited; * 2）Histologically or cytologically confirmed diagnosis of malignant hematologic diseases; * 3\) First time undergoing allogeneic hematopoietic stem cell transplantation; * 4\) ECOG score 0-2; * 5\) Hepatic and renal function, cardiopulmonary function meet the following requirements. * Serum creatinine ≤ 1.5 ULN; ②Left ventricular ejection fraction ≥ 45%; * Blood oxygen saturation \>91%; * Total bilirubin ≤ 2 × ULN; ALT and AST ≤ 3 × ULN; for ALT and AST abnormalities due to disease (e.g., liver infiltrates or bile duct obstruction), in the judgment of the investigator, the values may be adjusted to ≤ 5 × ULN; * 6\) Expected survival is longer than 12 weeks; * 7\) The subjects will voluntarily and strictly comply with the requirements of the study protocol and will sign a written informed consent form. Exclusion Criteria: * 1\) Prior treatment with ATG, ALG, or ATLG drugs within the past six months; * 2\) Allergic to any component of ATLG or ATG; * 3\) Bacterial, viral, parasitic, or mycobacterial infections not adequately controlled by treatment, i.e., inability to undergo hematopoietic stem cell transplantation due to severe infection. 4\) Women who are pregnant or breastfeeding, or participants of childbearing potential who are unwilling or unable to use effective methods of contraception; 5) Participants enrolled in another clinical trial (of any investigational drug or device) within 30 days prior to the subject's baseline visit. (Subjects enrolled in observational studies are eligible to participate). 6\) Any other circumstance that, in the judgment of the investigator, may interfere with the conduct of the clinical trial and the determination of the results of the trial.

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm leukemia lymphoma myelodysplastic syndrome

As listed by the trial registrant

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

Leukemia Lymphoma MDS

How to take part

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

The places running it

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

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

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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.

Can a different immune drug cut viral infections after stem cell transplants?

What the study statuses mean