Recruiting
Phase 1
Phase 2

Etentamig

Sponsor:

AbbVie

Code:

NCT06158854

Conditions

Immunoglobulin Light Chain (AL) Amyloidosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ABBV-383 (Etentamig)

Study Details

Brief 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. 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.

Conditions

Immunoglobulin Light Chain (AL) Amyloidosis

Study ID

NCT06158854

Start date

Apr 1, 2024

Status verified date

May, 2026

Completion date

Aug, 2031

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

76 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation: ABBV-383 (etentamig) Dose A

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

experimental: Dose Escalation: ABBV-383 (etentamig) Dose B

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

experimental: Dose Escalation: ABBV-383 (etentamig) Dose C

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

experimental: Dose Expansion: ABBV-383 (etentamig)

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

Interventions

ABBV-383 (Etentamig)

Intravenous Infusion

Primary outcome measure

  • Dose Escalation Only: Number of Participants with Dose-Limiting Toxicities (DLT) [ Time Frame: Up to 28 Days ]
  • Dose Expansion Only: Percentage of Participants who Achieve Hematologic Complete Response (CR) [ Time Frame: Up to 4 years ]
  • Dose Expansion Only: Number of Participants with DLTs [ Time Frame: Up to 4 years ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 4 years ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

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

Recruiting

Miami, Florida, United States, 33136

Boston Medical Center /ID# 255066

Recruiting

Boston, Massachusetts, United States, 02118

Mayo Clinic - Rochester /ID# 255258

Recruiting

Rochester, Minnesota, United States, 55905-0001

Icahn School of Medicine at Mount Sinai /ID# 255408

Recruiting

New York, New York, United States, 10029

Columbia University Medical Center /ID# 255068

Recruiting

New York, New York, United States, 10032-3729

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

Recruiting

New York, New York, United States, 10065-6007

Atrium Health Levine Cancer Institute /ID# 255074

Recruiting

Charlotte, North Carolina, United States, 28204

Atrium Health Wake Forest Baptist Medical Center /ID# 255851

Recruiting

Winston-Salem, North Carolina, United States, 27157

Oregon Medical Research Center /ID# 255119

Recruiting

Portland, Oregon, United States, 97239

Vanderbilt University Medical Center. /ID# 273510

Recruiting

Nashville, Tennessee, United States, 37232

University of Washington /ID# 261581

Recruiting

Seattle, Washington, United States, 98109

Wisconsin Medical Center /ID# 255836

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

AbbVie

Last update posted

May 13, 2026

Last verified

May, 2026

Keywords

  • Immunoglobulin Light Chain (AL) Amyloidosis
  • ABBV-383
  • TNB-383B

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-05-13.