NCT03933735: Phase 1: ABBV-383 (TNB-383B) in Subjects With Relapsed or Refractory Multiple Myeloma
Updated: Aug 27, 2022
ABBV-383 (formerly TNB-383B)
TNB-383B, a Bispecific Antibody Targeting BCMA
BCMA x CD3 T-cell engaging bispecifc antibody
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.