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ABBV-383 for the Treatment of Relapsed Refractory Waldenström Macroglobulinemia

NCT07420959 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-02-19

No results posted yet for this study

Summary

This phase I/II trial studies the side effects and best dose of ABBV-383 and to see how well it works in treating patients with Waldenström macroglobulinemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). ABBV-383 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).

Conditions

  • Recurrent Waldenstrom Macroglobulinemia
  • Refractory Waldenstrom Macroglobulinemia

Interventions

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

BIOLOGICAL

Etentamig

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Biospecimen Collection

Undergo blood and urine sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

Sponsors & Collaborators

Principal Investigators

  • Prashant Kapoor, MD · Mayo Clinic in Rochester

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-25
Primary Completion
2036-03-25
Completion
2038-03-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07420959 on ClinicalTrials.gov