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Immunoglobulin Light Chain (AL) AmyloidosisPhase 1/2NCT06158854

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

A Phase 1/2 study testing ABBV-383 (Etentamig) in people with Immunoglobulin Light Chain (AL) Amyloidosis, run by AbbVie at 23 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ABBV-383 (Etentamig)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
23 sitesin 6 countries
Study dates
1 Apr 2024to Aug 2031
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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);
Show all 12Show fewer
  • 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.

Trial locations and contacts

23 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

23 sites in 6 countries

United States12 sites, 12 recruiting

  • Boston Medical Center /ID# 255066

    Boston, Massachusetts, 02118

    Recruiting

  • Atrium Health Levine Cancer Institute /ID# 255074

    Charlotte, North Carolina, 28204

    Recruiting

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

    Miami, Florida, 33136

    Recruiting

  • Wisconsin Medical Center /ID# 255836

    Milwaukee, Wisconsin, 53226

    Recruiting

  • Vanderbilt University Medical Center. /ID# 273510

    Nashville, Tennessee, 37232

    Recruiting

  • Icahn School of Medicine at Mount Sinai /ID# 255408

    New York, New York, 10029

    Recruiting

  • Columbia University Medical Center /ID# 255068

    New York, New York, 10032-3729

    Recruiting

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

    New York, New York, 10065-6007

    Recruiting

  • Oregon Medical Research Center /ID# 255119

    Portland, Oregon, 97239

    Recruiting

  • Mayo Clinic - Rochester /ID# 255258

    Rochester, Minnesota, 55905-0001

    Recruiting

  • University of Washington /ID# 261581

    Seattle, Washington, 98109

    Recruiting

  • Atrium Health Wake Forest Baptist Medical Center /ID# 255851

    Winston-Salem, North Carolina, 27157

    Recruiting

Other trials in United States

Australia3 sites, 3 recruiting

  • Box Hill Hospital /ID# 255199

    Box Hill, Victoria, 3128

    Recruiting

  • Westmead Hospital /ID# 255200

    Westmead, New South Wales, 2145

    Recruiting

  • Princess Alexandra Hospital /ID# 255202

    Woolloongabba, Queensland, 4102

    Recruiting

Other trials in Australia

Japan3 sites, 3 recruiting

  • Kumamoto University Hospital /ID# 262579

    Kumamoto, Kumamoto, 8608556

    Site Coordinator, +81 96-344-2111

    Recruiting

  • Nagoya City University Hospital /ID# 256086

    Nagoya, Aichi-ken, 467-8602

    Recruiting

  • Japanese Red Cross Medical Center /ID# 256083

    Shibuya-ku, Tokyo, 150-8935

    Recruiting

Other trials in Japan

France2 sites, 2 recruiting

  • CHU Limoges - Dupuytren 1 /ID# 255370

    Limoges, Franche-Comte, 87042

    Recruiting

  • CHU Toulouse - Hopital Rangueil /ID# 255377

    Toulouse, Haute-Garonne, 31400

    Recruiting

Other trials in France

Italy2 sites, 2 recruiting

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

    Bologna, 40138

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo /ID# 255655

    Pavia, 27100

    Recruiting

Other trials in Italy

Greece1 site, 1 recruiting

  • Alexandra General Hospital /ID# 255542

    Athens, Attica, 11528

    Recruiting

Other trials in Greece

About this study

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

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.

Read more

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.

Being tested
ABBV-383 (Etentamig)
Keywords
Immunoglobulin Light Chain (AL) Amyloidosis, ABBV-383, TNB-383B
Medical subject headings
Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-383 (Etentamig)Drug

    Also called TNB-383B

    Intravenous Infusion

Study groups in NCT06158854
Study groupRoleWhat they receive
Dose Escalation: ABBV-383 (etentamig) Dose AExperimentalParticipants will receive ABBV-383 (etentamig) dose A during the approximately 2 year study duration.
Receives: Drug: ABBV-383 (Etentamig)
Dose Escalation: ABBV-383 (etentamig) Dose BExperimentalParticipants will receive ABBV-383 (etentamig) dose B during the approximately 2 year study duration.
Receives: Drug: ABBV-383 (Etentamig)
Dose Escalation: ABBV-383 (etentamig) Dose CExperimentalParticipants will receive ABBV-383 (etentamig) dose C during the approximately 2 year study duration.
Receives: Drug: ABBV-383 (Etentamig)
Dose Expansion: ABBV-383 (etentamig)ExperimentalParticipants will receive ABBV-383 (etentamig) expansion dose B during the approximately 2 year study duration.
Receives: Drug: ABBV-383 (Etentamig)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Escalation Only: Number of Participants with Dose-Limiting Toxicities (DLT)

    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.

    Measured: Up to 28 Days

  2. Dose Expansion Only: Percentage of Participants who Achieve Hematologic Complete Response (CR)

    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).

    Measured: Up to 4 years

  3. Dose Expansion Only: Number of Participants with DLTs

    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.

    Measured: Up to 4 years

  4. Number of Participants with Adverse Events (AEs)

    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.

    Measured: Up to 4 years

Secondary outcomes (6)

  1. Hematologic Overall Response Rate (ORR)

    Hematologic ORR is defined as partial response (PR) + very good partial response (VGPR) + complete remission (CR), proportion of participants who achieved a PR or better, per the modified IACC.

    Measured: Up to 4 Years

  2. Time to Hematologic CR

    Time to hematologic CR is defined as the time from first dose of study drug until CR, per the modified IACC.

    Measured: Up to 4 Years

  3. Duration of Hematologic CR

    Duration of hematologic CR is defined as the time from CR until disease progression, per the modified IACC.

    Measured: Up to 4 Years

  4. Organ Response Rate (OrRR)

    Organ response rate is defined as the time from first dose of study drug until to response in the heart kidney and liver, per the IACC.

    Measured: Up to 4 Years

  5. Time to Organ Response

    Time to organ response is defined as the time from first dose of study drug until organ response, per the IACC.

    Measured: Up to 4 Years

  6. Dose Escalation Only: Percentage of Participants who Achieve Hematologic CR Rate as Determined

    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).

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2023
  2. Study start1 Apr 2024
  3. Primary completionFeb 2028 (estimated)
  4. Study completionAug 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06158854
Sponsor's protocol ID
M24-209
Other IDs
2023-503429-20-00, 2023
Status last verified
May 2026
First submitted
28 Nov 2023
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ABBV-383 (Etentamig) in people with Immunoglobulin Light Chain (AL) Amyloidosis, run by AbbVie at 23 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Australia, Japan, France, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Escalation Only: Number of Participants with Dose-Limiting Toxicities (DLT) (time frame: Up to 28 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06158854.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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