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New antibody drug shows promise for Hard-to-Treat blood cancer

NCT ID NCT03933735

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called TNB-383B in about 220 adults with multiple myeloma that has come back or not responded to at least three prior treatments. The drug works by helping the immune system attack cancer cells. The main goals are to find the safest dose and check for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

220 people

The number who actually took part.

Started

Jun 2019

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has received three or more prior lines of therapy with exposure to a proteasome inhibitor (PI), an immunomodulatory imide (IMiD) and an anti-CD38 monoclonal antibody. * Must have adequate bone marrow function as defined in the protocol. * Must have an estimated glomerular filtration rate \>= 30 mL/min as estimated by the Modification of Diet in Renal Disease formula. * Must have total bilirubin \<= 1.5 × upper limit of normal (\[ULN\]; except if the subject has a known diagnosis of Gilbert's syndrome, in which case bilirubin must be \< 3 x ULN). * Serum calcium (corrected for albumin) at or below the ULN range. * Has Measurable Disease, defined as at least 1 of the following: * Serum M-protein \>= 0.5 g/dL (\>= 5 g/L). * Urine M-protein \>= 200 mg / 24h. * Serum free light chain (FLC) assay: Involved FLC level \>= 10 mg/dl (\>=100 mg/L) and an abnormal serum FLC ratio (\< 0.26 or \> 1.65). * Has confirmed evidence of relapse/progression from the immediately prior MM therapy, or participant is relapsed/refractory to the immediately prior MM therapy. * Consents to a fresh pretreatment bone marrow tumor biopsy or has adequate archival bone marrow tumor tissue that was collected within 6 months prior to screening and without intervening treatment. Exclusion Criteria: * Has been diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of basal cell or squamous cell carcinoma of the skin, in situ malignancy, low-risk prostate carcinoma after curative therapy, or complete resection/curative therapy of an advanced malignancy. * History of central nervous system involvement by their myeloma. * History of Grade \>= 3 peripheral neuropathy. * History of plasma cell leukemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome, or amyloidosis. * Has received another investigational drug within 21 days of enrollment. * Has ever received BCMA-targeted therapy. * Has received a autologous stem cell transplant within 12 weeks or an allogeneic stem cell transplant within 1 year of the first dose of study drug treatment. * Has any medical or psychiatric condition which in the opinion of the investigator or study Medical Monitor places the participant at an unacceptably high risk for toxicities, could interfere with successful or safe delivery of therapy, or could interfere with evaluation of the investigational product or interpretation of participant safety or study results. * Has received any therapy to treat cancer or undergone a major surgical procedure within 21 days, or within 5 half-lives of an anticancer drug, prior to the first dose of study treatment, whichever is shorter. * Has known active infection Grade \>= 2 requiring anti-infective treatment. * Has a history of major cardiac abnormalities. * Has unresolved adverse events as defined in the protocol.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

Contacts and locations

Locations

  • Atrium Health Levine Cancer Institute /ID# 238786

    Charlotte, North Carolina, 28204, United States

  • Atrium Health Wake Forest Baptist Medical Center /ID# 238787

    Winston-Salem, North Carolina, 27157, United States

  • Duplicate_Universitaetsklinikum Muenster /ID# 239637

    Münster, North Rhine-Westphalia, 48149, Germany

  • Mayo Clinic - Rochester /ID# 238683

    Rochester, Minnesota, 55905-0001, United States

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244831

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

  • Mt Sinai /ID# 242317

    New York, New York, 10029-6542, United States

  • Tulane University School of Medicine /ID# 242322

    New Orleans, Louisiana, 70112, United States

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 239638

    Dresden, Saxony, 01307, Germany

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 239636

    Hamburg, 20246, Germany

  • Universitaetsklinikum Koeln /ID# 239676

    Cologne, North Rhine-Westphalia, 50937, Germany

  • University of California San Francisco (UCSF) - Parnassus Heights /ID# 238680

    San Francisco, California, 94143, United States

  • University of North Carolina /ID# 238685

    Chapel Hill, North Carolina, 27514, United States

  • Washington University-School of Medicine /ID# 238681

    St Louis, Missouri, 63110, United States

  • Wisconsin Medical Center /ID# 238684

    Milwaukee, Wisconsin, 53226, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.