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NCT03933735Active, not recruitingPhase 1/2

A Study of TNB-383B in Participants With Relapsed or Refractory Multiple Myeloma

A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-383B, a Bispecific Antibody Targeting BCMA in Subjects With Relapsed or Refractory Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 6 Feb 2026

Brief summary (registry, in English)

This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of TNB-383B, a BCMA x CD3 T-cell engaging bispecific antibody, in participants with relapsed or refractory MM who have received at least 3 prior lines of therapy. The study consists of 4 portions, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B), Monotherapy once every 4 weeks (Q4W) dosing (Arm E), Monotherapy once every 3 weeks (Q3W) dosing (Arm F). Arm A will evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of escalating doses of single-agent TNB-383B, administered Q3W, in approximately 73 participants. Once the maximum tolerated dose (MTD) or recommended phase 2 dose, (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 48 participants each. Dose A will be evaluated as a monotherapy Q4W, in Arm E to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 20 participants. Dose C will be evaluated as a monotherapy, in Arm F to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 25 participants.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
220 (actual)
First submitted
26 Apr 2019
Start date
24 Jun 2019
Primary completion date
May 2026
Lead sponsor
AbbVie
NCT number
NCT03933735
EU CT number
2023-506993-11-00
EudraCT number
2020-000199-40

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 220
  • From 24 Jun 2019 to the primary completion date, May 2026
  • 12 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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 known active infection Grade \>= 2 requiring anti-infective treatment.
  • Has a history of major cardiac abnormalities.

Other

  • Has unresolved adverse events as defined in the protocol.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Coordinator of this site? Confirm its status
DresdenGermanyActive, not recruiting
University Medical Center Hamburg-Eppendorf
Coordinator of this site? Confirm its status
HamburgGermanyActive, not recruiting
University of North Carolina /ID# 238685
Coordinator of this site? Confirm its status
Chapel HillUnited StatesUnknown status
Atrium Health Levine Cancer Institute /ID# 238786
Coordinator of this site? Confirm its status
CharlotteUnited StatesUnknown status
Wisconsin Medical Center /ID# 238684
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesUnknown status
Tulane University School of Medicine /ID# 242322
Coordinator of this site? Confirm its status
New OrleansUnited StatesUnknown status
Mt Sinai /ID# 242317
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244831
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Mayo Clinic - Rochester /ID# 238683
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
University of California San Francisco (UCSF) - Parnassus Heights /ID# 238680
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
Washington University-School of Medicine /ID# 238681
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Atrium Health Wake Forest Baptist Medical Center /ID# 238787
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.