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Can a targeted drug trio tame a rare amyloid disease?

NCT ID NCT06629818

Disease control Sponsor: Peking Union Medical College Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether combining daratumumab, venetoclax, and dexamethasone can produce a deep and rapid response in people newly diagnosed with light-chain (AL) amyloidosis who carry a specific genetic marker called t(11;14). The study enrolls 36 participants and measures how well the treatment controls the disease at 3 months. The goal is to see if this oral-friendly regimen can become a new standard for this patient group.

What this could mean

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

Active substance
a combination of daratumumab, venetoclax, and dexamethasone
What this could lead to
If successful, this could offer a highly effective, oral-based treatment option for a specific genetic subtype of AL amyloidosis.
What could go wrong
This is a small, early-phase trial (36 participants) without a control group, so results may not generalize. The combination carries risks of infection and bone marrow suppression.

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 36 people

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

Started

Oct 2024

Expected to finish

Mar 2027

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: * Biopsy proved treatment-naïve AL amyloidosis * Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10% * dFLC \> 50mg/L Exclusion Criteria: * Co-morbidity of uncontrolled infection * Co-morbidity of other active malignancy * Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia * Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker) * Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia * Seropositive for human immunodeficiency virus * Hepatitis B virus (HBV)-DNA \> 1000 copies/mL * Seropositive for hepatitis C (except in the setting of a sustained virologic response) * Systemic treatment with moderate or strong cytochrome P450 3A （CYP3A） inducers, moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study drug * Neutrophil \<1×10E9/L，hemoglobin \< 8g/dL，or platelet \< 100×10E9/L * Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) \> 2.5 × upper limit of normal (ULN), total bilirubin \> 3 × ULN，eGFR \< 15 mL/min, or receiving renal replacement therapy

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Conditions

The condition(s) this trial relates to.

AL amyloidosis amyloidosis

As listed by the trial registrant

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

Light chain (AL) amyloidosis

Contacts and locations

Locations

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

More trials for these conditions

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