ABBV-383 for the Treatment of Relapsed Refractory Waldenström Macroglobulinemia (NCT07420959) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
ABBV-383 for the Treatment of Relapsed Refractory Waldenström Macroglobulinemia
United States38 participantsStarted 2026-03-25
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* PRE-REGISTRATION: Age ≥ 18 years
* PRE-REGISTRATION: Histological confirmation of relapsed and/or refractory Waldenstrom macroglobulinemia, with known prior exposure to a Bruton tyrosine kinase (BTK) inhibitor unless medically contraindicated. Note: although not preferred, archival bone marrow tumor tissue that was collected within 12 weeks prior to screening and without intervening anti- BCMA treatment may be used if the patient is unwilling to provide a fresh pretreatment marrow biopsy
* PRE-REGISTRATION: Measurable disease as defined as serum immunoglobulin M (IgM) levels ≥ 0.5 g/dL (500 mg/dL)
* PRE-REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* PRE-REGISTRATION: Subject is naïve to treatment with ABBV-383 or anti-BCMA bispecific antibodies
* PRE-REGISTRATION: Hemoglobin ≥ 8.0 g/dL (obtained ≤ 14 days prior to pre-registration)
* PRE-REGISTRATION: Absolute neutrophil count (ANC) ≥ 1000/mm\^3 \[neutropenia due to marrow infiltration may be supported by granulocyte colony-stimulating factor (GCSF)\] (obtained ≤ 14 days prior to pre-registration). Transfusion and/or growth factor support is permitted prior to assessment, but neutrophils, platelets, and hemoglobin must be stable for ≥ 72 hours after transfusion and/or growth factor administration for the subject to be eligible
* PRE-REGISTRATION: Platelet count ≥ 75,000/mm\^3 (obtained ≤ 14 days prior to pre-registration) EXCEPTION: If thrombocytopenia deemed…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD) of etentamig (ABBV-383) (Phase 1)
Timeframe: Up to 1 cycle (Cycle length = 28 days)
2
Very good partial response (VGPR) or better response as the best response achieved (Phase 2)
Timeframe: Within 12 cycles of initiation of therapy (Cycle length = 28 days)