ASH 2021 | Phase I study of TNB-383B in R/R multiple myeloma

Shaji Kumar, MD, Mayo Clinic, Rochester, MN, discusses the design and findings of the ongoing Phase I first-in-human dose-escalation/expansion study of TNB-383B, a novel bispecific antibody targeting BCMA and CD3 in patients with relapsed/refractory (R/R) multiple myeloma (NCT03933735). There are currently 118 patients enrolled in this study, and they have received a median of six prior lines of therapy. In the patient group treated with a 40 mg or higher dose, it appeared that TNB-383B was well tolerated, with adverse events such as hematological toxicity and low-grade cytokine release syndrome (CRS) observed in over 50% of patients. Overall response rates (ORR) were 81% among patients in the dose-escalation phase after a median follow-up of 8 months and 53% in patients in both the dose-expansion and dose-escalation phases after a median follow-up of 4 months. In addition, over half of triple-class refractory patients responded to therapy. Overall, TNB-383B appears to be effective and safe in this heavily pre-treated patient population. This interview took place at the 63rd ASH Annual Meeting and Exposition congress in Atlanta, GA.