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Engineered donor cells aim to shield transplant patients from dangerous viruses

NCT ID NCT07672964

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This trial tests whether giving patients a special type of donor immune cell, called CD45RA-depleted DLI, can prevent serious viral infections after a stem cell transplant. The study includes 30 high-risk patients who have received a transplant for blood cancer. Researchers will monitor for infections like CMV and EBV, and check how well the immune system recovers.

What this could mean

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

Active substance
CD45RA-depleted donor lymphocyte infusion
What this could lead to
If it works, this approach could reduce the risk of life-threatening viral infections after stem cell transplants, improving survival and recovery.
What could go wrong
This is an early-phase trial with only 30 participants, so results may not apply broadly. The treatment itself may cause side effects like graft-versus-host disease.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 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

14 to 50 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: Participants must meet all of the following criteria: * Patients undergoing allogeneic hematopoietic stem cell transplantation (any conditioning regimen or graft source is allowed). * Presence of at least one high-risk factor for post-transplant viral infection (any of the following): * Age ≥50 years or ≤14 years * Non-sibling matched transplantation * In vivo or ex vivo T-cell depletion * Myeloablative conditioning * Conditioning containing radiotherapy * Second transplantation * CMV IgG or EBV IgG donor/recipient mismatch (donor positive, recipient negative) * History of grade II or higher acute graft-versus-host disease (aGVHD) after transplantation and use of high-dose corticosteroids (prednisone equivalent ≥1 mg/kg/day) * Availability of a suitable lymphocyte donor (see "Donor Selection Criteria"). * Adequate organ function meeting the following laboratory criteria: * Liver function: ALT and AST ≤10× upper limit of normal (ULN); total bilirubin ≤5× ULN * Renal function: BUN and creatinine ≤1.25× ULN * No cardiac dysfunction on electrocardiogram or echocardiogram * Pulmonary function: oxygen saturation \>90% without supplemental oxygen * The patient or legal guardian has the desire and request to receive treatment, signs the informed consent form before treatment, and is willing to comply with the treatment plan, follow-up schedule, and laboratory tests. Exclusion Criteria: Patients meeting any of the following criteria will be excluded from this study: * Active grade II-IV acute graft-versus-host disease (aGVHD) * Active aGVHD requiring prednisone or equivalent corticosteroid \>0.5 mg/kg/day * Active viral infection * Uncontrolled or relapsed malignancy * Other serious acute or chronic physical or psychiatric conditions, or laboratory abnormalities, that may compromise patient safety or compliance, or affect informed consent, study participation, follow-up, or interpretation of results.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Ruijin Hospital

    Shanghai, SH, 200025, China

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