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Cancer drug could ease rare nerve disorder

NCT ID NCT07392229

Disease control Sponsor: Azienda Ospedaliera di Padova 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study tests whether zanubrutinib, a drug used for certain blood cancers, can improve nerve function in people with anti-MAG neuropathy—a rare condition causing numbness, weakness, and balance problems. About 50 adults in Italy will take the drug for 12 months. Researchers will check if symptoms get better using standard nerve tests.

What this could mean

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

Active substance
Zanubrutinib (a targeted cancer drug that blocks a protein called BTK)
What this could lead to
If successful, this could offer a new treatment option for a rare nerve disease that currently has few effective therapies.
What could go wrong
This is an early-phase trial with only 50 participants and no placebo group, so results may not be definitive. The drug also carries risks like infection and bleeding.

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 50 people

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

Started

Mar 2026

Expected to finish

Mar 2031

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 (MAIN): * age ≥18 years; * diagnosis of anti-MAG antibody polyneuropathy; * neurophysiological (ENG/EMG) evidence of a demyelinating polyneuropathy with evidence of disproportionately prolonged distal motor latency in one or more nerves -excluding the median nerve if related to carpal tunnel syndrome * IgM monoclonal protein underlying MGUS (based on the WHO definition of clonal lympho- plasmocytes \<10%), Waldenstrom macroglobulinemia (based on the WHO definition of clonal lympho-plasmocytes ≥10%), marginal zone lymphoma, chronic lymphocytic leukemia or low- grade lymphoma not otherwise specified; * presence of anti MAG antibodies (titer ≥ 7.000 BTU); * neurophysiological (ENG/EMG) evidence of demyelinating polyneuropathy. Exclusion Criteria (MAIN): * Previous treatment with BTK inhibitors * Aggressive non-Hodgkin lymphoma or IgM multiple myeloma * Evidence of moderate or severe motor nerve axonal damage, defined when occurring diffuse polyneuropathic denervation or a recruitment pattern lower than intermediate in ≥50% of muscles examined, and/or INCAT at lower limbs ≥4. * ECOG \>3 * Use of strong CYP3A inducers within 14 days prior to the first dose of zanubrutinib

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Conditions

The condition(s) this trial relates to.

polyneuropathy associated with IgM monoclonal gammapathy with anti-MAG

As listed by the trial registrant

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

Anti-mag IgM-associated demyelinating polyneuropathy

How to take part

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

  1. The places running it

    5 sites. 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

  • CTU Ematologia, Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, Milan, 20162, Italy

  • SC Ematologia 1 - Fondazione IRCCS Policlinico San Matteo

    RECRUITING

    Pavia, PV, 27100, Italy

  • SC UCO Ematologia, Ospedale Maggiore di Trieste

    RECRUITING

    Trieste, Trieste, 34129, Italy

  • UOC Ematologia, Azienda Ospedale Università Padova

    RECRUITING

    Padova, PD, 35128, Italy

  • UOSD Leucemia Linfatica Cronica, Fondazione Policlinico Universitario "A. Gemelli", IRCCS

    RECRUITING

    Roma, RM, 00168, Italy