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Triple therapy aims to overcome antibody barrier in Half-Matched stem cell transplants

NCT ID NCT07698080

Disease control Sponsor: Hematology department of the 920th hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 13, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study tests whether a combination of dexamethasone, intravenous immunoglobulin (IVIG), and extra donor immune cells can safely lower harmful antibodies that attack donor stem cells in half-matched (haploidentical) transplants. The trial enrolls 60 adults aged 18–65 with blood cancers or disorders like leukemia, lymphoma, or aplastic anemia who have these antibodies and no other suitable donor. Participants receive the three treatments just before and during transplant, with the goal of preventing graft failure and improving transplant success.

What this could mean

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

Active substance
Dexamethasone, intravenous immunoglobulin (IVIG), and donor mononuclear cells
What this could lead to
If successful, this approach could offer a safer, simpler way to make half-matched stem cell transplants work for patients who have harmful antibodies against their donor.
What could go wrong
This is a mid-stage trial with only 60 participants, so results may not apply to everyone. The extra immune cells could increase the risk of graft-versus-host disease, a serious complication.

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 60 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 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 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. Diagnosis of benign or malignant hematological diseases (including leukemia, lymphoma, thalassemia, aplastic anemia, myelodysplastic syndromes, etc.) confirmed by NCCN guidelines, and determined by the investigator to require allogeneic hematopoietic stem cell transplantation. 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3. 3. Donor-specific antibody (DSA) mean fluorescence intensity (MFI) \> 500. 4. Age between 18 and 65 years (age limits are also captured separately in the eligibility module). 5. Body weight between 40 kg and 100 kg. 6. No other suitable donor available (i.e., no DSA-negative related donor or unrelated donor). Exclusion Criteria: 1. Patients unsuitable for transplantation or without willingness to undergo transplantation, or diagnosed with non-hematological diseases. 2. Estimated life expectancy \< 1 month. 3. Known allergy to any drug or intervention used in the study regimen. 4. Pregnancy, lactation, active severe infection, or severe major organ dysfunction. 5. Severe psychiatric or neurological disorders that may affect the ability to provide informed consent and/or to report adverse events or comply with observation. 6. Refusal or inability to sign the informed consent form.

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Conditions

The condition(s) this trial relates to.

aplastic anemia leukemia lymphoma myelodysplastic syndrome Myelodysplastic Syndromes thalassemia

As listed by the trial registrant

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

Aplastic anemia Leukemia Lymphoma Myelodysplastic syndromes Thalassemia

How to take part

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  1. 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 ↗

  2. A doctor treating you

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