Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

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 (NCT06158854) is a Phase 1 / Phase 2 interventional studying Immunoglobulin Light Chain (AL) Amyloidosis, sponsored by AbbVie. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Immunoglobulin Light Chain (AL) Amyloidosis, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 76 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Immunoglobulin Light Chain (AL) Amyloidosis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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); ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

ABBV-383 (Etentamig)

Intravenous Infusion

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856

Miami, Florida, United States

Boston Medical Center /ID# 255066

Boston, Massachusetts, United States

Mayo Clinic - Rochester /ID# 255258

Rochester, Minnesota, United States

Icahn School of Medicine at Mount Sinai /ID# 255408

New York, New York, United States

Columbia University Medical Center /ID# 255068

New York, New York, United States

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255073

New York, New York, United States

Atrium Health Levine Cancer Institute /ID# 255074

Charlotte, North Carolina, United States

Atrium Health Wake Forest Baptist Medical Center /ID# 255851

Winston-Salem, North Carolina, United States

Oregon Medical Research Center /ID# 255119

Portland, Oregon, United States

University of Washington /ID# 261581

Seattle, Washington, United States

Wisconsin Medical Center /ID# 255836

Milwaukee, Wisconsin, United States

Westmead Hospital /ID# 255200

Westmead, New South Wales, Australia

Princess Alexandra Hospital /ID# 255202

Woolloongabba, Queensland, Australia

Box Hill Hospital /ID# 255199

Box Hill, Victoria, Australia

CHU Limoges - Dupuytren 1 /ID# 255370

Limoges, Franche-Comte, France

CHU Toulouse - Hopital Rangueil /ID# 255377

Toulouse, Haute-Garonne, France

Alexandra General Hospital /ID# 255542

Athens, Attica, Greece

IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255654

Bologna, Italy

Nagoya City University Hospital /ID# 256086

Nagoya, Aichi-ken, Japan

Kumamoto University Hospital /ID# 262579

Kumamoto, Kumamoto, Japan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06158854), the sponsor (AbbVie), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06158854 clinical trial studying?

Who can participate in NCT06158854?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06158854?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06158854. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06158854. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.