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LetterLetter
Open Access

Phase I clinical study of humanized BCMA-single-domain antibodies targeting CAR-T in patients with relapsed or refractory multiple myeloma

Gaofeng Zheng, Ruyi Xu, Heng Mei, Xiaoyan Han, Donghua He, Yanling Weng, Cheng Wen, Zhuoxiao Cao and Zhen Cai
Cancer Biology & Medicine October 2025, 20240581; DOI: https://doi.org/10.20892/j.issn.2095-3941.2024.0581
Gaofeng Zheng
1Multiple Myeloma Treatment Center and Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310006, China
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Ruyi Xu
1Multiple Myeloma Treatment Center and Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310006, China
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Heng Mei
2Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China
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Xiaoyan Han
1Multiple Myeloma Treatment Center and Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310006, China
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Donghua He
1Multiple Myeloma Treatment Center and Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310006, China
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Yanling Weng
1Multiple Myeloma Treatment Center and Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310006, China
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Cheng Wen
3Shanghai Simnova Biotechnology Co., Ltd, Shanghai 200120, China
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Zhuoxiao Cao
3Shanghai Simnova Biotechnology Co., Ltd, Shanghai 200120, China
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Zhen Cai
1Multiple Myeloma Treatment Center and Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310006, China
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  • ORCID record for Zhen Cai
  • For correspondence: caiz{at}zju.edu.cn
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    Table 1

    Grade ≥3 treatment-emergent adverse events during the study

    Grade ≥3 adverse events2.5 × 106 CAR-BCMA/kg (n = 3)5.0 × 106 CAR-BCMA/kg (n = 11)7.5 × 106 CAR-BCMA/kg (n = 1)Total (n = 15)
    Hematologic toxicities, n (%)
     Neutropenia3 (100.0)10 (90.9)114 (93.3)
     Leukopenia3 (100.0)8 (72.7)112 (80.0)
     Lymphopenia2 (66.7)8 (72.7)111 (73.3)
     Anemia2 (66.7)6 (54.5)19 (60.0)
     Thrombocytopenia03 (27.3)14 (26.7)
     Myelosuppression01 (9.1)01 (6.7)
    Infectious disease, n (%)
     Infection02 (18.2)13 (20)
     Upper respiratory infection01 (9.1)01 (6.7)
     Escherichia sepsis01 (9.1)01 (6.7)
     Infectious enterocolitis01 (9.1)01 (6.7)
     Pneumonia01 (9.1)01 (6.7)
    Metabolic and nutritional diseases, n (%)
     Hypokalemia02 (18.2)02 (13.3)
    Kidney and urological diseases, n (%)
     Renal calculus01 (9.1)01 (6.7)
    Others, n (%)
     Hypofibrinogenemia01 (9.1)01 (6.7)
     Ferritin increased1 (33.3)1 (9.1)02 (13.3)
     Interleukin increased01 (9.1)01 (6.7)

    CAR-T, chimeric antigen receptor T cell; BCMA, B cell maturation antigen.

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    Cancer Biology & Medicine: 22 (12)
    Cancer Biology & Medicine
    Vol. 22, Issue 12
    15 Dec 2025
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    Phase I clinical study of humanized BCMA-single-domain antibodies targeting CAR-T in patients with relapsed or refractory multiple myeloma
    Gaofeng Zheng, Ruyi Xu, Heng Mei, Xiaoyan Han, Donghua He, Yanling Weng, Cheng Wen, Zhuoxiao Cao, Zhen Cai
    Cancer Biology & Medicine Oct 2025, 20240581; DOI: 10.20892/j.issn.2095-3941.2024.0581

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    Phase I clinical study of humanized BCMA-single-domain antibodies targeting CAR-T in patients with relapsed or refractory multiple myeloma
    Gaofeng Zheng, Ruyi Xu, Heng Mei, Xiaoyan Han, Donghua He, Yanling Weng, Cheng Wen, Zhuoxiao Cao, Zhen Cai
    Cancer Biology & Medicine Oct 2025, 20240581; DOI: 10.20892/j.issn.2095-3941.2024.0581
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      • Clinical characteristics and disposition
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