ABBV-383 for the Treatment of Relapsed Refractory Waldenström Macroglobulinemia

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07420959
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Recurrent Waldenstrom Macroglobulinemia
  • Refractory Waldenstrom Macroglobulinemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood and urine sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Etentamig — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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).

Key Dates

Start date
Mar 25, 2026
Status verified
Feb 2026
Primary completion
Mar 25, 2036
Completion
Mar 25, 2038

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ABBV-383)
    Patients receive ABBV-383 IV as a single push or over 30 minutes to 4 hours on days 1 and 4 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET/CT during screening and blood and urine sample collection and bone marrow aspiration and biopsy throughout the trial. Additionally, patients with extramedullary disease undergo CT or PET/CT throughout the trial.

Primary Outcome Measure

Maximum tolerated dose (MTD) of etentamig (ABBV-383) (Phase 1) [ Time Frame: Up to 1 cycle (Cycle length = 28 days) ]

Central Contacts

  • Clinical Trials Referral Office
    855-776-0015
    [email protected]
  • Cancer Center Clinical Trials Study Coordinator
    507-293-6386

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Cancer Center Clinical Trials Study Coordinator
507-293-6386
Prashant Kapoor, MD (PRINCIPAL_INVESTIGATOR)

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