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ACTIVE NOT RECRUITING
NCT03933735
PHASE1/PHASE2

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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

Interventions

DRUG

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