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LCAR-B38M is a chimeric antigen receptor T-cell (CAR T-cell) therapy that dually binds two distinct B cell maturation antigen (BCMA) epitopes, making it distinct from the other BCMA directed CAR T-cell therapies currently in trials. LCAR-B38M is currently under investigation in the LEGEND-2 trial (NCT03090659); a single-arm, open-label, multicenter phase I study in patients with relapsed/refractory multiple myeloma (RRMM). Wan-Hong Zhao from the Second Affiliated Hospital of Xi’an Jiaotong University, ShaanXi, China, and colleagues published the phase I data in the Journal of Hematology & Oncology on 20th December 2018. The primary outcome of the LEGEND-2 study was to evaluate the safety of LCAR-B38M CAR T cells and the secondary objective was to evaluate anti-myeloma response of the treatment.
Patients underwent leukapheresis. The CD3+ T cells were transduced with a LCAR-B38M lentiviral vector to express anti-BCMA CAR and were then expanded ex vivo with interleukin-2 stimulation. Lymphodepletion by cyclophosphamide, 300 mg/m2, was given on days -5, -4 and -3. Total weight adjusted CAR+ T cell dose (median: 0.5 x 106 cells/kg [0.07–2.1 x 106]) was delivered as 3 infusions (20, 30 and 50%), 5 days after lymphodepleting chemotherapy started, over the course of 7 days.
Data cut-off date was 6th February 2018
This phase I, first-in human clinical study of LCAR-B38M shows a manageable safety profile with durable responses in patients with RRMM. Efficacy was consistent across subgroups, including previous ASCT status, age, number of prior therapies and type or prior therapy. The analysis of the efficacy and safety of LCAR-B38M is ongoing in a phase Ib/II trial in the US (NCT03548207).
CAR T-cell therapies in clinical development in China
An overview of current clinical trials in hematologic malignancies in China presented by Jianxiang Wang during the 2nd European CAR T Meeting, Sitges, ES
LEGEND-2 and CARTITUDE-1: CAR T for relapsed/refractory multiple myeloma
Summary of two abstracts from ASH reporting results from trials using the CAR T-cell product known as LCAR-B38M in China and JNJ 68284528 (JNJ 4528) in the United States (U.S).
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