Under construction – not a live service
Sign in
Taking peoplePhase 1/2

Etentamig for adults with AL amyloidosis that returned or did not respond

Tests etentamig given into a vein in adults with AL amyloidosis.

Key facts

Who runs it
AbbVie
Where
Limoges Cedex 1 and Toulouse Cedex 9, FranceSee the 2 sitesAlso in 5 other countries, 21 sites
Registry title
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
Status
Recruiting
Phase
Phase 1/2
People taking part
76 people, planned
Started
1 Apr 2024
Expected to end
Aug 2031
Type of study
Interventional, 4 groups
Treatments tested
  • ABBV-383 (Etentamig)
Record updated
13 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with AL amyloidosis that came back or did not respond to earlier treatment. They get the study drug etentamig (ABBV-383) through a vein.

Age
18 years or older
Sex
All sexes can join
Disease stage
Primary systemic AL amyloidosis with at least 1 organ affected. Cardiac risk stage 1, 2, 3a, or 3b if heart function and markers were stable for 3 months. Measurable disease: dFLC of 50 mg/L or more, or meeting high-risk dFLC progression criteria after the last therapy. ECOG performance status of 2 or less.
Earlier treatment
Must have had a proteasome inhibitor and an anti-CD38 monoclonal antibody before. Cannot have had an autologous stem cell transplant within 12 weeks or an allogeneic one within 1 year of the first dose.
Biomarker or test result
dFLC (difference between involved and uninvolved free light chains) of 50 mg/L or more, or meeting high-risk dFLC progression criteria after the last therapy.

Main reasons for not taking part

  • Other types of amyloid disease that are not AL
  • Symptomatic multiple myeloma, active plasma cell leukemia, or Waldenström's macroglobulinemia
  • Organ transplant that needs ongoing immunosuppressant drugs
  • Acute infection in the last 14 days needing treatment through a vein
  • Major surgery within 28 days before the first dose, or planned during the study

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 in France

Also in 5 other countries, 21 sites

  • Centre Hospitalier Et Universitaire De LimogesLimoges Cedex 1, FranceNo longer taking part
  • Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceNo longer taking part

About the trial

What the trial wants to find out

Immunoglobulin light chain (AL) amyloidosis is the most common form of systemic amyloidosis. AL amyloidosis has many root causes and is characterized by the overproduction of AL that are secreted by clonal bone marrow plasma cells. This is a study to determine adverse events and change in disease activity in adult participants with AL amyloidosis treated with ABBV-383.

Read full original descriptionShow less

Etentamig (ABBV-383) is an investigational drug being developed for the treatment of AL amyloidosis. This study in broken into 2 parts (dose escalation and dose expansion) with 4 arms. During dose escalation (arms 1-3) participants will receive 1 of 3 doses of ABBV-383 to determine the part 2 dose. After completion of the dose escalation portion of the study, the dose expansion (part 2) portion of the study will begin. One arm (arm 4) will begin and participants will receive a dose determined during the dose escalation portion (part 1). Around 76 adult participants with relapsed/refractory AL amyloidosis will be enrolled at approximately 25 sites across the world.

Participants will receive Etentamig (ABBV-383) as an infusion into the vein for up to approximately 2 year study duration.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

The 4 groups in the trial

  • Dose Escalation: ABBV-383 (etentamig) Dose ATreatment being tested

    Participants will receive ABBV-383 (etentamig) dose A during the approximately 2 year study duration.

    Treatment: ABBV-383 (Etentamig)

  • Dose Escalation: ABBV-383 (etentamig) Dose BTreatment being tested

    Participants will receive ABBV-383 (etentamig) dose B during the approximately 2 year study duration.

    Treatment: ABBV-383 (Etentamig)

  • Dose Escalation: ABBV-383 (etentamig) Dose CTreatment being tested

    Participants will receive ABBV-383 (etentamig) dose C during the approximately 2 year study duration.

    Treatment: ABBV-383 (Etentamig)

  • Dose Expansion: ABBV-383 (etentamig)Treatment being tested

    Participants will receive ABBV-383 (etentamig) expansion dose B during the approximately 2 year study duration.

    Treatment: ABBV-383 (Etentamig)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
An Open-Label Phase 1/2 Study Evaluating the Safety and Efficacy of Etentamig (ABBV-383) in AL Amyloidosis
Plain-language title
Etentamig for adults with AL amyloidosis that returned or did not respondGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
13 May 2026