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Assessing the effects of Etentamig on AL Amyloidosis in adults

An Open-Label Phase 1/2 Study Evaluating the Safety and Efficacy of Etentamig (ABBV-383) in AL Amyloidosis

Phase1; Phase2 Interventional AbbVie · NCT06158854

This study is testing a new drug called Etentamig to see if it can help adults with AL amyloidosis feel better and manage their symptoms.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment76 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Locations23 sites (Miami, Florida and 22 other locations)
Trial IDNCT06158854 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of Etentamig (ABBV-383), an investigational drug, in adult participants diagnosed with immunoglobulin light chain (AL) amyloidosis. The trial is divided into two parts: a dose escalation phase to determine optimal dosing and a safety expansion phase to further assess the drug's effects. Participants will receive one of three doses during the first part, followed by one of two doses in the second part, with a total of around 76 participants expected to enroll. The study aims to monitor changes in disease activity and any adverse events associated with the treatment.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with primary systemic AL amyloidosis who have previously been treated with specific therapies.

Not a fit: Patients with other non-AL amyloid diseases or those with symptomatic multiple myeloma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from AL amyloidosis.

How similar studies have performed: While this approach is novel, similar studies targeting AL amyloidosis have shown promise in the past.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Miami, Florida and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Immunoglobulin Light Chain AmyloidosisABBV-383TNB-383B
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.