NCT03933735: Phase 1: ABBV-383 (TNB-383B) in Subjects With Relapsed or Refractory Multiple Myeloma
- Active, not recruiting
- Dec 5, 2019
- 2 min read
Updated: Feb 10, 2024
ABBV-383 (formerly TNB-383B)
TNB-383B, a Bispecific Antibody Targeting BCMA
BCMA x CD3 T-cell engaging bispecifc antibody
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