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ASH 2020 | FHVH-BCMA-T CAR T-cell therapy shows efficacy in R/R myeloma
Lekha Mikkilineni, MD, National Institutes of Health, Bethesda, MD, shares the results of a first-in-human trial (NCT03602612) of an anti-BCMA chimeric antigen receptor (CAR) T-cell therapy, named FHVH-BCMA-T, for the treatment of relapsed/refractory (R/R) multiple myeloma. FHVH-BCMA-T expresses a fully-human heavy-chain-only anti-BCMA binding domain rather than a traditional single-chain variable fragment, the function of which is to reduce host immune responses against the treatment. Five dose levels were trialled in patients following lymphodepletion. Efficacy and toxicity considerations identified 6 x 10^6 CAR+ T-cells/kg as the maximum feasible dose. An impressive overall response rate of 90% was achieved, with responses proving durable in the majority of patients who received higher dose levels. 19% of patients experienced grade 3 cytokine release syndrome. The deep and durable responses and proven tolerability seen in this trial support FHVH-BCMA-T use. Enrolment into an expansion cohort has begun. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.
