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idecabtagene vicleucel(ide-cel,bb2121)治疗复发/难治性多发性骨髓瘤日本患者的 2 期结果。

Phase 2 results of idecabtagene vicleucel (ide-cel, bb2121) in Japanese patients with relapsed and refractory multiple myeloma.

机构信息

Division of Hematology, Department of Medicine, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan.

Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.

出版信息

Int J Hematol. 2023 May;117(5):729-737. doi: 10.1007/s12185-023-03538-6. Epub 2023 Jan 24.


DOI:10.1007/s12185-023-03538-6
PMID:36690910
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10121508/
Abstract

BACKGROUND: In the phase 2 KarMMa trial, patients with relapsed/refractory multiple myeloma (RRMM) achieved deep and durable responses with idecabtagene vicleucel (ide-cel), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T cell therapy. Here we report a sub-analysis of the Japanese cohort of KarMMa. METHODS: Adult patients with RRMM who had received  ≥ 3 prior treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and had disease refractory to last treatment received ide-cel at a target dose of 450 × 10 CAR positive T cells. RESULTS: Nine patients were treated with ide-cel. The overall response rate was 89% (median follow-up, 12.9 months). The best overall response was stringent complete response in 5 patients (56%), very good partial response in 3 (33%), and stable disease in 1. Median duration of response was not reached. All patients experienced grade ≤ 2 cytokine release syndrome and one patient experienced grade 2 neurotoxicity, but all resolved. Two patients died, one each from plasma cell myeloma and general health deterioration. CONCLUSION: Ide-cel yielded deep, durable responses with a tolerable and predictable safety profile in Japanese patients with RRMM. These results are similar to those of the non-Japanese population in KarMMa.

摘要

背景:在 2 期 KarMMa 试验中,复发/难治性多发性骨髓瘤(RRMM)患者接受 B 细胞成熟抗原导向嵌合抗原受体(CAR)T 细胞疗法 idecabtagene vicleucel(ide-cel)治疗后,取得了深度和持久的缓解。在此,我们报告 KarMMa 日本队列的亚分析结果。

方法:接受过≥3 种先前治疗方案(包括蛋白酶体抑制剂、免疫调节剂和抗 CD38 抗体)治疗且对最后一次治疗耐药的 RRMM 成年患者,按目标剂量 450×106 CAR 阳性 T 细胞给予 ide-cel。

结果:9 例患者接受 ide-cel 治疗。总体缓解率为 89%(中位随访时间 12.9 个月)。最佳总体缓解为 5 例(56%)患者达到严格完全缓解,3 例(33%)患者达到非常好的部分缓解,1 例患者达到疾病稳定。缓解持续时间未达到中位数。所有患者均出现≤2 级细胞因子释放综合征,1 例患者出现 2 级神经毒性,但均得到缓解。2 例患者死亡,分别死于浆细胞瘤和一般健康状况恶化。

结论:ide-cel 在日本 RRMM 患者中具有深度和持久的缓解作用,且安全性可预测、耐受性良好。这些结果与 KarMMa 中的非日本人群相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9fe/10121508/e5b5db11ad29/12185_2023_3538_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9fe/10121508/f505cc72626e/12185_2023_3538_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9fe/10121508/1af153471958/12185_2023_3538_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9fe/10121508/e5b5db11ad29/12185_2023_3538_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9fe/10121508/f505cc72626e/12185_2023_3538_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9fe/10121508/1af153471958/12185_2023_3538_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9fe/10121508/e5b5db11ad29/12185_2023_3538_Fig3_HTML.jpg

相似文献

[1]
Phase 2 results of idecabtagene vicleucel (ide-cel, bb2121) in Japanese patients with relapsed and refractory multiple myeloma.

Int J Hematol. 2023-5

[2]
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[3]
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[4]
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[5]
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[6]
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[7]
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[8]
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J Clin Oncol. 2023-4-10

[9]
Patient experience before and after treatment with idecabtagene vicleucel (ide-cel, bb2121): qualitative analysis of patient interviews in the KarMMa trial.

Leuk Res. 2022-9

[10]
Recent Advances in the Use of Chimeric Antigen Receptor-Expressing T-Cell Therapies for Treatment of Multiple Myeloma.

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引用本文的文献

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[2]
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Int J Hematol. 2025-5-9

[3]
Achieving stringent complete remission in relapsed/refractory multiple myeloma with liver extramedullary disease after CAR‑T cell therapy: A case report.

Oncol Lett. 2025-3-28

[4]
Role of Chimeric Antigen Receptor T-Cells in the Evolving Therapeutic Landscape of Multiple Myeloma: A Literature Review.

Cureus. 2025-3-5

[5]
Treatment of Multiple Myeloma in Patients Refractory to Daratumumab/Anti-CD38 Monoclonal Antibodies: A Systematic Review.

Cancer Med. 2025-3

[6]
Unveiling causal immune cell-gene associations in multiple myeloma: insights from systematic reviews and Mendelian randomization analyses.

Front Med (Lausanne). 2025-1-22

[7]
Efficacy and safety of chimeric antigen receptor T cells targeting BCMA and GPRC5D in relapsed or refractory multiple myeloma.

Front Immunol. 2024-12-23

[8]
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Int J Mol Med. 2025-2

[9]
Impact of Allogeneic Stem Cell Transplant on Safety and Outcomes of Chimeric Antigen Receptor T Cell (CAR-T) Therapy in Patients with Multiple Myeloma (MM).

J Clin Med. 2024-10-18

[10]
Measurable Residual Disease Testing in Multiple Myeloma Following T-Cell Redirecting Therapies.

Cancers (Basel). 2024-9-27

本文引用的文献

[1]
Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study.

Cancer. 2021-11-15

[2]
Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study.

Lancet. 2021-7-24

[3]
KarMMa-RW: comparison of idecabtagene vicleucel with real-world outcomes in relapsed and refractory multiple myeloma.

Blood Cancer J. 2021-6-18

[4]
Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma.

N Engl J Med. 2021-2-25

[5]
Melflufen and Dexamethasone in Heavily Pretreated Relapsed and Refractory Multiple Myeloma.

J Clin Oncol. 2021-3-1

[6]
Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study.

Lancet. 2020-9-1

[7]
Oral Selinexor-Dexamethasone for Triple-Class Refractory Multiple Myeloma.

N Engl J Med. 2019-8-22

[8]
Anti-BCMA CAR T-Cell Therapy bb2121 in Relapsed or Refractory Multiple Myeloma.

N Engl J Med. 2019-5-2

[9]
JSH practical guidelines for hematological malignancies, 2018: III. Myeloma-1. Multiple myeloma (MM).

Int J Hematol. 2019-5

[10]
Outcomes of patients with multiple myeloma refractory to CD38-targeted monoclonal antibody therapy.

Leukemia. 2019-3-11

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