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
- Diseases
- Multiple myeloma
- 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
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| University of North Carolina /ID# 238685 Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Atrium Health Levine Cancer Institute /ID# 238786 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Wisconsin Medical Center /ID# 238684 Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Tulane University School of Medicine /ID# 242322 Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Mt Sinai /ID# 242317 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244831 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mayo Clinic - Rochester /ID# 238683 Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of California San Francisco (UCSF) - Parnassus Heights /ID# 238680 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Washington University-School of Medicine /ID# 238681 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Atrium Health Wake Forest Baptist Medical Center /ID# 238787 Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.