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A phase 1, open-label study of LCAR-B38M, a chimeric antigen receptor T cell therapy directed against B cell maturation antigen, in patients with relapsed or refractory multiple myeloma

Open access
Zhao, Wan-Hong, Liu, Jie, Wang, Bai-Yan, Chen, Yin-Xia, Cao, Xing-Mei, Yang, Yun, Zhang, Yi-Lin, Wang, Fang-Xia, Zhang, Peng-Yu, Lei, Bo, Gu, Liu-Fang, Wang, Jian-Li, Yang, Nan, Zhang, Ru, Zhang, Hui, Shen, Ying, Bai, Ju, Xu, Yan, Wang, Xu-Geng, Zhang, Rui-Li, Wei, Li-Li, Li, Zong-Fang, Li, Zhen-Zhen, Geng, Yan, He, Qian, Zhuang, Qiu-Chuan, Fan, Xiao-Hu, He, Ai-Li, Zhang, Wang-Gang·2018·Journal of Hematology & Oncology

Abstract

BACKGROUND: Chimeric antigen receptor (CAR) T cell therapy has demonstrated proven efficacy in some hematologic cancers. We evaluated the safety and efficacy of LCAR-B38M, a dual epitope-binding CAR T cell therapy directed against 2 distinct B cell maturation antigen epitopes, in patients with relapsed/refractory (R/R) multiple myeloma (MM). METHODS: ]) were infused in 3 separate infusions. The primary objective is to evaluate the safety of LCAR-B38M CAR T cells; the secondary objective is to evaluate the antimyeloma response of the treatment based on the general guidelines of the International Myeloma Working Group. RESULTS: At data cutoff, 57 patients had received LCAR-B38M CAR T cells. All patients experienced ≥ 1 adverse events (AEs). Grade ≥ 3 AEs were reported in 37/57 patients (65%); most common were leukopenia (17/57; 30%), thrombocytopenia (13/57; 23%), and aspartate aminotransferase increased (12/57; 21%). Cytokine release syndrome occurred in 51/57 patients (90%); 4/57 (7%) had grade ≥ 3 cases. One patient reported neurotoxicity of grade 1 aphasia, agitation, and seizure-like activity. The overall response rate was 88% (95% confidence interval [CI], 76 to 95); 39/57 patients (68%) achieved a complete response, 3/57 (5%) achieved a very good partial response, and 8/57 (14%) achieved a partial response. Minimal residual disease was negative for 36/57 (63%) patients. The median time to response was 1 month (range, 0.4 to 3.5). At a median follow-up of 8 months, median progression-free survival was 15 months (95% CI, 11 to not estimable). Median overall survival for all patients was not reached. CONCLUSIONS: LCAR-B38M CAR T cell therapy displayed a manageable safety profile and demonstrated deep and durable responses in patients with R/R MM. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03090659 ; Registered on March 27, 2017, retrospectively registered.

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Metadata

Authors
Zhao, W.-H., Liu, J., Wang, B.-Y., Chen, Y.-X., Cao, X.-M., Yang, Y., Zhang, Y.-L., Wang, F.-X., Zhang, P.-Y., Lei, B., Gu, L.-F., Wang, J.-L., Yang, N., Zhang, R., Zhang, H., Shen, Y., Bai, J., Xu, Y., Wang, X.-G., Zhang, R.-L., Wei, L.-L., Li, Z.-F., Li, Z.-Z., Geng, Y., He, Q., Zhuang, Q.-C., Fan, X.-H., He, A.-L., & Zhang, W.-G.
Venue
Journal of Hematology & Oncology
Published
2018-12
Volume
11
Issue
1
Pages
141-141
ISSN
1756-8722 (ISSN-L)
OpenAlex
W2906581363
Cited by
518
References
29
FWCI
20.31
Type
journal article
Language
en
Open access
gold

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CoChat. (2026). Citation check: A phase 1, open-label study of LCAR-B38M, a chimeric antigen receptor T cell therapy directed against B cell maturation antigen, in patients with relapsed or refractory multiple myeloma. https://app.cochat.ai/papers/10.1186/s13045-018-0681-6
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Zhao, W.-H., Liu, J., Wang, B.-Y., Chen, Y.-X., Cao, X.-M., Yang, Y., Zhang, Y.-L., Wang, F.-X., Zhang, P.-Y., Lei, B., Gu, L.-F., Wang, J.-L., Yang, N., Zhang, R., Zhang, H., Shen, Y., Bai, J., Xu, Y., Wang, X.-G., . . . Zhang, W.-G. (2018). A phase 1, open-label study of LCAR-B38M, a chimeric antigen receptor T cell therapy directed against B cell maturation antigen, in patients with relapsed or refractory multiple myeloma. Journal of Hematology & Oncology. https://doi.org/10.1186/s13045-018-0681-6

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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