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New antibody treatment aims to shield transplant patients from dangerous virus

NCT ID NCT05370976

Disease control Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called Cytotect, which contains antibodies against the CMV virus, to prevent CMV infection in people who had a stem cell transplant and developed graft-versus-host disease (GVHD). These patients are at high risk for CMV, and current antiviral drugs often cause serious side effects. The trial was very small and was stopped early, so we cannot draw firm conclusions about how well Cytotect works.

What this could mean

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

Active substance
Cytotect (hyperimmune anti-CMV immunoglobulin)
What this could lead to
If it works, this could provide a safer way to prevent CMV infection in high-risk transplant patients, avoiding the severe side effects of current antiviral drugs.
What could go wrong
This was a very small, early-phase trial that was terminated early with only 2 participants, so results are not reliable. The drug may not prevent CMV infection effectively.

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

2 people

The number who actually took part.

Started

Sep 2022

Finished

Aug 2023

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: * Able to provide informed consent * Patients before day from 29 days to 150 days of first allo-HCT * Any indication, any stem cell source, any conditioning, any donor type or HLA-matching * Patients with positive CMV-serostatus before transplant * Patients with first episode of grade II-IV acute GVHD requiring systemic corticosteroids ≥1 mg/kg/day * Absence of CMV infection at the time of inclusion * Absence of other viral infections (EBV, adenovirus, BK virus) at the time of inclusion * Absence of dialysis * Absence of thrombotic microangiopathy * Absence of macrophage activation syndrome Exclusion Criteria: * \- Patients receiving corticosteroids \> 0.5 mg/kg/day for more than 5 days before inclusion * Uncontrolled CMV infection within 02 weeks before inclusion * Inability to understand the investigational nature of the study or to give informed consent * ECOG Performance Status ≥ 3 * Evidence of relapse of underlying disease * Patients receiving or having received anti-CMV treatment within 30 days before inclusion (acyclovir and valacyclovir are not considered as CMV prophylaxis) * Hypersensitivity to Cytotect®CP or to any of the excipients * Hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA * Patients with any contra-indication to Cytotect®CP * Females either pregnant/breast-feeding or planning to become pregnant * Patients developing post-DLI grade II-IV acute GVHD * Freedom privacy * Absence of medical insurance cover

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease cytomegalovirus infection prevention target

As listed by the trial registrant

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

Cytomegalovirus infections

Contacts and locations

Locations

  • Hop Claude Huriez Chu Lille

    Lille, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.