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NCT03933735: Phase 1: ABBV-383 (TNB-383B) in Subjects With Relapsed or Refractory Multiple Myeloma

Updated: Feb 10

  • ABBV-383 (formerly TNB-383B)

  • TNB-383B, a Bispecific Antibody Targeting BCMA

  • BCMA x CD3 T-cell engaging bispecifc antibody


ABBV-383 (formerly TNB-383B)

RRMM


NCT03933735: Phase 1: A Study of TNB-383B in Subjects With Relapsed or Refractory Multiple Myeloma


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 subjects with relapsed or refractory MM who have received at least 3 prior lines of therapy. The study consists of 2 portions, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Arm A will evaluate the safety, tolerability, PK and PD profiles of escalating doses of single-agent TNB-383B, administered once every 3 weeks (Q3W), in approximately 85 subjects. 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, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of the MTD/RP2D dose of TNB 383B monotherapy in approximately 48 subjects.


Sponsor

TeneoOne Inc.


Collaborator

AbbVie


Multiple locations

 

ClinicalTrials.gov Identifier: NCT03933735


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


First Posted : May 1, 2019


Click here to see details on ClinicalTrials.gov

 

anti-alpha BCMA/anti-alpha CD3 T-cell engaging bispecific antibody TNB-383B

 

900 A Phase 1 First-in-Human Study of Tnb-383B, a BCMA x CD3 Bispecific T-Cell Redirecting Antibody, in Patients with Relapsed/Refractory Multiple Myeloma

Program: Oral and Poster Abstracts

Type: Oral

Session: 653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Immune Therapy for Multiple Myeloma

Hematology Disease Topics & Pathways:

Clinical Trials, Biological, Antibody Therapy, Bispecific Antibody Therapy, Clinical Research, Plasma Cell Disorders, Diseases, Immunotherapy, Therapies, Lymphoid Malignancies, Monoclonal Antibody Therapy

Monday, December 13, 2021: 7:30 PM


Learn more:

 

OAB-055-Updated results of a phase 1, first-in-human study of ABBV383, a BCMA × CD3 bispecific T-cell redirecting antibody, in patients with relapsed/refractory multiple myeloma


#IMS2022 - 19th International Myeloma Society Annual Meeting; August 25-27, 2022 - LA, California


 

* TNB-383B

* anti-BCMA x aCD3 T-BsAb TNB-383B

* anti-BCMA x aCD3 T-cell engaging bispecific antibody TNB-383B

*ABBV-383


ABBV-383 (formerly TNB-383B)

 

- California: University of California San Francisco

- Minnesota: Mayo Clinic Rochester Minnesota

- Missouri: Washington University School of Medicine Saint Louis

- North Carolina: Wake Forest Baptist Health Winston-Salem

- Wisconsin: Froedtert Memorial Milwaukee

 

Locations

United States, California

United States, Indiana

United States, Louisiana

United States, Michigan

United States, Minnesota

United States, Missouri

United States, New York

United States, North Carolina

United States, Texas

United States, Wisconsin

Europe

Germany




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