A Study of TNB-383B in Subjects With Relapsed or Refractory Multiple Myeloma
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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 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.