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Recurrent Waldenstrom MacroglobulinemiaPhase 1/2NCT07420959

ABBV-383 for the Treatment of Relapsed Refractory Waldenström Macroglobulinemia

A Phase 1/2 study testing Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy in people with Recurrent Waldenstrom Macroglobulinemia and Refractory Waldenstrom Macroglobulinemia, run by Mayo Clinic at 1 site in United States.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
30 Sep 2026to 30 Sep 2036
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

  • 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)
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  • 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 to be related to the bone marrow infiltration (disease burden) by WM cells, platelet count threshold of ≥ 50,000 is acceptable. 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: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to pre-registration) (except for subjects with documented Gilbert's syndrome, in which case direct bilirubin must be ≤ 2 x ULN)
  • PRE-REGISTRATION: Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (obtained ≤ 14 days prior to pre-registration)
  • PRE-REGISTRATION: Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained ≤ 14 days prior to pre-registration)
  • PRE-REGISTRATION: Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula (obtained ≤ 14 days prior to pre-registration)
  • PRE-REGISTRATION: Negative pregnancy test done ≤ 7 days prior to pre-registration, for persons of childbearing potential only. Note: Subjects must have 2 negative results for pregnancy tests prior to initiating therapy. The first test (serum) should be performed during the screening period prior to first dose of study drug and the second test (urine, minimum sensitivity of 25 IU/L). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • PRE-REGISTRATION: Willing to follow strict birth control measures as suggested by the study
  • PRE-REGISTRATION: Female participants: Female participant is eligible to participate if she is not pregnant or breast feeding, and at least one of the following conditions applies:
  • Is not a woman of childbearing potential (WOCBP) OR
  • Due to the risk for embryo-fetal toxicity and prescribed under a pregnancy prevention/controlled distribution program, WOCBP participants will be eligible if they commit to either:
  • Abstain continuously from heterosexual sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
  • To use birth control as follows:
  • Two methods of reliable birth control (one method that is highly effective and one additional effective (barrier) method), beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide treatment
  • PRE-REGISTRATION: Male patients: Male participants are eligible to participate if they agree to the following from the time of first dose of study treatment until 28-days after the last dose of lenalidomide, to allow for clearance of any altered sperm:
  • Refrain from donating sperm PLUS either:
  • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR
  • Must agree to use contraception/barrier as detailed below:
  • Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of < 1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females)
  • Note: Subjects of childbearing potential must practice at least one of the specified method of birth control with partner(s) initiated prior to first dose of study drug administration to 90 days after the last dose of study drug. These methods include the following:
  • A barrier method of contraception (including male and female condoms with or without spermicide) plus one of the following hormonal contraceptives:
  • Combined (estrogen and progestogen containing) hormonal contraception associated with the inhibition of ovulation
  • Oral, intravaginal or transdermal
  • Progestogen-only hormonal contraception associated with the inhibition of ovulation
  • Oral, injectable, implantable
  • An intrauterine device (IUD)
  • Intrauterine hormone-releasing system (IUS)
  • Bilateral tubal occlusion
  • Vasectomized partner
  • Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment, starting the day prior to first dose of study drug, for the duration of the study, and for 90 days after the last dose of study drug). Total sexual abstinence should only be used as a contraceptive method if it is in line with the subjects' usual and preferred lifestyle. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to the investigational medicinal product (IMP), and withdrawal are not acceptable methods of contraception.
  • PRE-REGISTRATION: Provide written informed consent and is willing to comply with the tests required per the protocol
  • PRE-REGISTRATION: Willingness to provide mandatory blood and bone marrow samples specimens for correlative research
  • PRE-REGISTRATION: Rochester only: Willingness to enroll in Institutional Review Board (IRB) #521-93
  • REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance
  • REGISTRATION: Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. Note: Subjects must have 2 negative results for pregnancy tests prior to initiating therapy. The first test (serum) should be performed during the screening period prior to first dose of study drug and the second test (urine, minimum sensitivity of 25 IU/L). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • REGISTRATION: Subject was pre-registered ≤ 14 days prior to registration

Who cannot join

  • PRE-REGISTRATION: Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:
  • Pregnant persons
  • Nursing persons
  • Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
  • PRE-REGISTRATION: Subject has known allergic reaction, significant sensitivity, or intolerance to constituents of the study drugs (and excipients) and/or other products in the same class
  • PRE-REGISTRATION: Any of the following prior therapies:
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  • Major surgery ≤ 4 weeks prior to registration
  • Chemotherapy ≤ 2 weeks prior to registration
  • An investigational therapy, including chemotherapy, radiotherapy, biological, immunotherapy or targeted small molecule agents within 5 half-lives (or 2 weeks, if half-life is unknown) prior to registration
  • Patient has received steroid therapy given with anti-neoplastic intent ≤ 7 days prior registration
  • Autologous stem cell transplant ≤ 12 weeks or allogeneic transplant ≤ 24 weeks prior to registration
  • Organ transplant requiring continued use of immunosuppressants
  • Live, attenuated vaccines ≤ 4 weeks prior to registration
  • Received a monoclonal antibody given with anti-neoplastic intent ≤ 30 days prior to registration
  • PRE-REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • PRE-REGISTRATION: Immunocompromised patients and patients with a known history of human immunodeficiency virus (HIV). Subjects with HIV may be permitted provided that the subject has an undetectable HIV viral load by standard clinical assays on antiretroviral medication [Highly Active Antiretroviral Therapy (HAART)] and is able to tolerate study treatment per investigator's judgement. Subjects with active, hepatitis C virus or active hepatitis B virus infection [subjects with resolved infection (hepatitis B virus surface antigen (HbsAg) negative, but hepatitis B virus core antibody (antiHBc) or hepatitis B virus surface antibody (antiHBs) positive] must be screened using real-time polymerase chain reaction (PCR) of hepatitis B virus (HBV) deoxyribonucleic acid (DNA).
  • PRE-REGISTRATION: Uncontrolled intercurrent life threatening illness including, but not limited to:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Any organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the metabolism of ABBV 383 or put the study outcomes at undue risk specifically
  • A subject with history of stroke or intracranial hemorrhage within ≤ 24 weeks prior to registration
  • Concurrent light and/or heavy chain amyloidosis or central nervous system (CNS) involvement with Waldenström Macroglobulinemia (WM) (Bing Neel syndrome)
  • Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Note: If a subject has signs/symptoms suggestive of SARS-CoV-2 infection, the subject must have a negative molecular (e.g., PCR) test or 2 negative-antigen test results at least 24 hours apart. Subjects who meet SARS-CoV-2 infection exclusion criteria must be screen failed and may only rescreen after they meet the following SARS-CoV-2 infection viral clearance criteria
  • PRE-REGISTRATION: Other active malignancy other than WM ≤ 3 years prior to registration EXCEPTIONS: with the exception of a) adequately treated in situ carcinoma of the cervix uteri, b) adequately treated basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, c) prostate cancer Gleason grade 6 or lower AND with stable prostate specific antigen levels off treatment; d) previous malignancy confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study
  • REGISTRATION: If any of the following exist at screening, subject will not be eligible for trial because this trial involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception (per protocol)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

Cancer Center Clinical Trials Study Coordinator contact

507-293-6386

United States1 site, 1 recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Cancer Center Clinical Trials Study Coordinator, 507-293-6386

    Recruiting

Other trials in United States

About this study

Official title: Phase 1/2 Trial of ABBV-383 for Patients With Relapsed Refractory Waldenström Macroglobulinemia

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).

Being tested
Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Etentamig
Medical subject headings
Waldenstrom Macroglobulinemia

What participants receive

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

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood and urine sample collection

  • Bone Marrow AspirationProcedure or surgery

    Undergo bone marrow aspiration

  • Bone Marrow BiopsyProcedure or surgery

    Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow

    Undergo bone marrow biopsy

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT or PET/CT

  • EtentamigBiological

    Also called ABBV 383, ABBV-383, ABBV383, Anti-alpha BCMA/Anti-alpha CD3 T-cell Engaging Bispecific Antibody TNB-383B

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT07420959
Study groupRoleWhat they receive
Treatment (ABBV-383)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Biological: Etentamig; Procedure: Positron Emission Tomography; Other: Questionnaire Administration

What is being measured

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

  1. Maximum tolerated dose (MTD) of etentamig (ABBV-383) (Phase 1)

    MTD is defined as the highest tested dose level that is determined to have acceptable toxicity and tolerability based on dose-limiting toxicity (DLT) definitions. An unacceptable dose level is one that induces DLT in at least one-third of patients (at least 2 of a maximum of 6 new patients). The MTD of ABBV-383 thus will be the highest tested dose level where at most one out of 6 patients treated have a reported DLT.

    Measured: Up to 1 cycle (Cycle length = 28 days)

  2. Very good partial response (VGPR) or better response as the best response achieved (Phase 2)

    The International Workshop on Waldenström's Macroglobulinemia-11 (IWWM-11) Response Criteria will be used for response assessment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

    Measured: Within 12 cycles of initiation of therapy (Cycle length = 28 days)

Secondary outcomes (7)

  1. Major response rate (MRR)

    Will be estimated by the total number of patients who achieve partial response (PR) or better divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true major response rate will be calculated.

    Measured: At 6 and 12 months

  2. Progression-free survival (PFS)

    PFS is defined as the time from registration to the earliest date of documentation of disease progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.

    Measured: 6 and 12 months

  3. Time to response

    Time to response is defined in patients who have achieved a response as the time from registration to the first incidence of a response. Will be summarized descriptively and will include time to the first response (defined as the time between the date of the registration and the first documented evidence of a minor response or better), major (defined as the time between the date of registration and the first documented evidence of a partial response or better), and best response during the study period.

    Measured: Up to 2 years

  4. Duration of response

    Duration of response is defined for all evaluable patients who have achieved an objective response as the time from which the patient's objective status is first noted to be a PR or better to the earliest date on which progressive disease or death due to any cause is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.

    Measured: Up to 2 years

  5. Time to next treatment

    Time to next treatment is defined as the time from registration to the initiation of subsequent anti-Waldenström macroglobulinemia (WM) therapy. The distribution of time to next treatment will be estimated using the method of Kaplan-Meier.

    Measured: Up to 2 years

  6. Overall survival (OS)

    OS is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.

    Measured: Up to 2 years

  7. Incidence of adverse events (AEs)

    The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns. AEs will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Immune effector cell associated neurotoxicity syndrome (ICANS) and cytokine release syndrome (CRS) will also be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.

    Measured: Up to 90 days from last dose of administration of the study drug

Timeline

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

  1. First posted19 Feb 2026
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion30 Sep 2036 (estimated)
  4. Study completion30 Sep 2036 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07420959
Sponsor's protocol ID
MC230817
Other IDs
25-007511
Status last verified
Sep 2026
First submitted
5 Feb 2026
Last updated
5 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy in people with Recurrent Waldenstrom Macroglobulinemia and Refractory Waldenstrom Macroglobulinemia, run by Mayo Clinic at 1 site in United States.

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 42 inclusion and 31 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of etentamig (ABBV-383) (Phase 1) (time frame: Up to 1 cycle (Cycle length = 28 days)). The study lists 2 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 NCT07420959.

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 5 Oct 2026.

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