NCT06158854RecruitingPhase 1/2
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
An Open-Label Phase 1/2 Study Evaluating the Safety and Efficacy of Etentamig (ABBV-383) in AL Amyloidosis
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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. 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- First submitted
- 28 Nov 2023
- Start date
- 1 Apr 2024
- Primary completion date
- Feb 2028
- Lead sponsor
- AbbVie
- Diseases
- Amyloidosis
- NCT number
- NCT06158854
- EU CT number
- 2023-503429-20-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 76
- From 1 Apr 2024 to the primary completion date, Feb 2028
- 23 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Box Hill Hospital /ID# 255199 Coordinator of this site? Confirm its status | Box Hill | Australia | Recruiting |
| Westmead Hospital /ID# 255200 Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
| Princess Alexandra Hospital /ID# 255202 Coordinator of this site? Confirm its status | Woolloongabba | Australia | Recruiting |
| Centre Hospitalier Et Universitaire De Limoges Coordinator of this site? Confirm its status | Limoges Cedex 1 | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Active, not recruiting |
| Kumamoto University Hospital /ID# 262579 Coordinator of this site? Confirm its status | Kumamoto | Japan | Recruiting |
| Nagoya City University Hospital /ID# 256086 Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Japanese Red Cross Medical Center /ID# 256083 Coordinator of this site? Confirm its status | Shibuya-ku | Japan | Recruiting |
| Boston Medical Center /ID# 255066 Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Atrium Health Levine Cancer Institute /ID# 255074 Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856 Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Wisconsin Medical Center /ID# 255836 Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Vanderbilt University Medical Center. /ID# 273510 Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255073 Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Columbia University Medical Center /ID# 255068 Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Icahn School of Medicine at Mount Sinai /ID# 255408 Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Oregon Medical Research Center /ID# 255119 Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Mayo Clinic - Rochester /ID# 255258 Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| University of Washington /ID# 261581 Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Atrium Health Wake Forest Baptist Medical Center /ID# 255851 Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.