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New hope for rare blood disease: experimental drug targets tough amyloidosis cases

NCT ID NCT07039578

Disease control Sponsor: Keymed Biosciences Co.Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called CM336 in 90 adults whose primary light-chain amyloidosis has come back or not responded to prior treatments. The drug is designed to help the immune system attack the abnormal cells causing the disease. The main goal is to see how many patients achieve a complete blood response, meaning the harmful proteins are no longer detectable.

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 90 people

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

Started

Jul 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Voluntary provision of written informed consent and ability to comply with protocol requirements. * Age ≥18 years, any gender. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. * Confirmed diagnosis of primary light-chain (AL) amyloidosis. * Relapsed or refractory primary AL amyloidosis. * Measurable hematologic disease at screening (per protocol-defined criteria). * Involvement of ≥1 amyloid-affected organ. * Adequate organ function meeting all protocol-specified criteria within 3 days prior to first dose. Exclusion Criteria: * Current or prior diagnosis of multiple myeloma. * Received anti-AL amyloidosis therapy within protocol-specified timeframe prior to first dose. * Clinically significant cardiovascular or cerebrovascular disease. * Any active or uncontrolled infection meeting protocol-defined criteria. * Any other condition deemed by the Investigator to preclude safe study participation.

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Conditions

The condition(s) this trial relates to.

AL amyloidosis primary systemic amyloidosis

As listed by the trial registrant

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

Primary light-chain amyloidosis

How to take part

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

  1. The places running it

    2 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

  • Institute of Hematology & Blood Diseases Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

More trials for these conditions

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