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A Study of TNB-383B in Participants With Relapsed or Refractory Multiple Myeloma
Sponsor: AbbVie
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2019-06-24
Completion Date
2026-05
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
TNB-383B
Intravenous (IV) Injection
Locations (14)
University of California San Francisco (UCSF) - Parnassus Heights /ID# 238680
San Francisco, California, United States
Tulane University School of Medicine /ID# 242322
New Orleans, Louisiana, United States
Mayo Clinic - Rochester /ID# 238683
Rochester, Minnesota, United States
Washington University-School of Medicine /ID# 238681
St Louis, Missouri, United States
Mt Sinai /ID# 242317
New York, New York, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244831
New York, New York, United States
University of North Carolina /ID# 238685
Chapel Hill, North Carolina, United States
Atrium Health Levine Cancer Institute /ID# 238786
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 238787
Winston-Salem, North Carolina, United States
Wisconsin Medical Center /ID# 238684
Milwaukee, Wisconsin, United States
Universitaetsklinikum Koeln /ID# 239676
Cologne, North Rhine-Westphalia, Germany
Duplicate_Universitaetsklinikum Muenster /ID# 239637
Münster, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 239638
Dresden, Saxony, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 239636
Hamburg, Germany