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A Study of Etentamig (ABBV-383) for AL Amyloidosis

This study is testing a new medicine called Etentamig (ABBV-383) for adults with Immunoglobulin Light Chain (AL) amyloidosis. AL amyloidosis is a condition where abnormal proteins build up in organs. The study aims to see how safe Etentamig (ABBV-383) is and if it helps improve the disease. It will also look at any side effects. You may be able to join if you are an adult with AL amyloidosis, have an ECOG performance status of 2 or less, and have at least one organ affected by the disease. The study will consider it a success if participants achieve a complete response in their blood tests or if there are no serious side effects. The current status of this study is unclear, and it plans to enroll 76 participants.

Study design
This is an interventional study with two parts: dose escalation and dose expansion, involving 76 participants. It is testing different doses of Etentamig (ABBV-383).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants in the dose expansion part of the study will be followed for up to 4 years to check for complete response and side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06158854

A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Immunoglobulin Light Chain (AL) Amyloidosis Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion

Recruiting
PHASE1Ages 18+InterventionalTreatment
AbbVie
~76 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:ABBV-383 (Etentamig)

At a glance

Recruiting sites
23 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation Only: Number of Participants with Dose-Limiting Toxicities (DLT)
Measured over Up to 28 Days
+3 more outcomes measured

Conditions

Immunoglobulin Light Chain (AL) Amyloidosis

Explore related trials

Primary Amyloidosis

Where it's being run

23 sites across 19 states
New York3
North Carolina2
Italy2
Florida1
Massachusetts1
Minnesota1
Oregon1
Tennessee1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of primary systemic immunoglobulin light chain (AL) amyloidosis.
Eastern Cooperative Oncology Group (ECOG) performance status of \<= 2.
Have at least 1 organ historically impacted by AL amyloidosis.
Considered AL amyloidosis cardiac risk stage 1, 2, or 3a, or considered risk stage 3b with stable cardiac function and markers for 3 months prior to dosing, and have measurable disease of AL amyloidosis as defined by difference between involved and uninvolved free light chains (dFLC) \>= 50 mg/L or meeting high-risk dFLC progression criteria after immediate prior line of therapy.
Has previously been exposed to a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.

Exclusion

Known history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
Known allergic reaction, significant sensitivity, or intolerance to constituents of the study treatment (and excipients) and/or other products in the same class.
Participant has the following conditions:
Other non-AL amyloid disease;
Previous or current diagnosis of symptomatic multiple myeloma (MM), including the presence of lytic bone disease, plasmacytomas, \>= 60% plasma cells in the bone marrow, or hypercalcemia (defined as corrected calcium \> 11 mg/dL);
Active plasma cell leukemia (i.e., either 20% of peripheral white blood cells or \> 2.0 × 109/L circulating plasma cells by standard differential);
Waldenström's macroglobulinemia;
Acute diffuse infiltrative pneumopathy;
Major surgery within 28 days prior first dose or planned during study participation;
History of organ transplant requiring continued use of immunosuppressants;
Acute infections within 14 days prior first dose requiring parenteral therapy (antibiotic, antifungal, or antiviral);
Participant has received an autologous stem cell transplant (SCT) within 12 weeks or an allogeneic SCT within 1 year of the first dose of study treatments.

What this trial measures

  • Dose Escalation Only: Number of Participants with Dose-Limiting Toxicities (DLT)Up to 28 Days

    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

  • Dose Expansion Only: Percentage of Participants who Achieve Hematologic Complete Response (CR)Up to 4 years

    Hematologic CR is defined as the percentage of participants who achieve normalization of free light chain levels, negative serum immunofixation, negative urine immunofixation as determined per the modified International Amyloidosis Consensus Criteria (IACC).

  • Dose Expansion Only: Number of Participants with DLTsUp to 4 years

    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

  • Number of Participants with Adverse Events (AEs)Up to 4 years

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.