Phase 2 study of relmacabtagene autoleucel (CD19 CAR-T) for relapsed/refractory mantle cell lymphoma in Chinese adults

Relmacabtagene autoleucel (relma-cel), an anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, is approved in China for relapsed/refractory (R/R) large B-cell lymphoma and follicular lymphoma. This phase 2, open-label, single-arm, multicenter study evaluated its efficacy and safety in Chinese patients with heavily pretreated R/R mantle cell lymphoma (MCL). A total of 70 patients with R/R MCL who had received 1 to 9 previous therapies (including anthracycline or bendamustine chemotherapy, anti-CD20 antibodies, and Bruton tyrosine kinase [BTK] inhibitors) were enrolled. Of these, 59 received a single infusion of 100 × 106 CAR-positive T cells following leukapheresis. The primary end point was the objective response rate (ORR) at 3 months after infusion, assessed using the Lugano 2014 criteria. Secondary end points included the duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. At 3 months, the ORR was 71.19% (95% confidence interval [CI], 57.92-82.24) with a complete response rate of 59.32% (95% CI, 45.75-71.93). After a median follow-up of 13.3 months (95% CI, 9.04-18.69), the median DOR was 18.1 months, PFS was 15.5 months, and OS was 19.5 months. Grade 3 or higher treatment-emergent adverse events were common, including neutropenia (76.3%), leukopenia (69.5%), and lymphopenia (47.5%). Severe cytokine release syndrome and neurotoxicity occurred in 6.8% of patients each, and all cases resolved fully. No fatal events were reported. These findings demonstrate that relma-cel offers high response rates, durable remissions, and manageable safety in Chinese patients with R/R MCL. This trial was registered at www.clinicaltrials.gov as #NCT04718883.

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Publication Details

Journal
Blood Advances
Published
2025-08-14
DOI
https://doi.org/10.1182/bloodadvances.2024015763
Citations
1
Primary Topic
CAR-T cell therapy research
Type
article
Field-Weighted Citation Impact
1.05
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article

Phase 2 study of relmacabtagene autoleucel (CD19 CAR-T) for relapsed/refractory mantle cell lymphoma in Chinese adults

Dehui Zou, Ziqiang Tian, Jun Zhu, Yan Xie et al.
1 citations
Blood Advances
CAR-T cell therapy research
1.05
article

Phase 2 study of relmacabtagene autoleucel (CD19 CAR-T) for relapsed/refractory mantle cell lymphoma in Chinese adults

Dehui Zou, Ziqiang Tian, Jun Zhu, Yan Xie, Aibin Liang, Yongen Gu, Heng Mei, Keshu Zhou, Junning Cao, Hongmei Jing, Wenyu Li, Tong Chen, Jie Jin, Huiqiang Huang, Pengcheng He, Lanfang Li, Zhen Xia, Haiyan Yang, Zhengming Jin
article en
1 citations

Abstract

Relmacabtagene autoleucel (relma-cel), an anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, is approved in China for relapsed/refractory (R/R) large B-cell lymphoma and follicular lymphoma. This phase 2, open-label, single-arm, multicenter study evaluated its efficacy and safety in Chinese patients with heavily pretreated R/R mantle cell lymphoma (MCL). A total of 70 patients with R/R MCL who had received 1 to 9 previous therapies (including anthracycline or bendamustine chemotherapy, anti-CD20 antibodies, and Bruton tyrosine kinase [BTK] inhibitors) were enrolled. Of these, 59 received a single infusion of 100 × 106 CAR-positive T cells following leukapheresis. The primary end point was the objective response rate (ORR) at 3 months after infusion, assessed using the Lugano 2014 criteria. Secondary end points included the duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. At 3 months, the ORR was 71.19% (95% confidence interval [CI], 57.92-82.24) with a complete response rate of 59.32% (95% CI, 45.75-71.93). After a median follow-up of 13.3 months (95% CI, 9.04-18.69), the median DOR was 18.1 months, PFS was 15.5 months, and OS was 19.5 months. Grade 3 or higher treatment-emergent adverse events were common, including neutropenia (76.3%), leukopenia (69.5%), and lymphopenia (47.5%). Severe cytokine release syndrome and neurotoxicity occurred in 6.8% of patients each, and all cases resolved fully. No fatal events were reported. These findings demonstrate that relma-cel offers high response rates, durable remissions, and manageable safety in Chinese patients with R/R MCL. This trial was registered at www.clinicaltrials.gov as #NCT04718883.

Blood AdvancesVol. 10(4)
Tongji University (CN), Union Hospital (HK), Sun Yat-sen University (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Peking University (CN), Fudan University (CN), Guangdong General Hospital (CN), Tianjin Medical University Cancer Institute and Hospital (CN), Zhengzhou University (CN), Soochow University (CN), Fudan University Shanghai Cancer Center (CN), Peking University Cancer Hospital (CN), Zhejiang Cancer Hospital (CN), First Affiliated Hospital of Xi'an Jiaotong University (CN), Shanghai Chengtou (China) (CN), Peking University Third Hospital (CN), Henan Cancer Hospital (CN), Guangdong Academy of Medical Sciences (CN), Sun Yat-sen University Cancer Center (CN), Ministry of Education (ET), Institute of Hematology & Blood Diseases Hospital (CN), First Affiliated Hospital of Soochow University (CN), Shanghai Clinical Research Center (CN), Huashan Hospital (CN), Tongji Hospital (CN), First Affiliated Hospital Zhejiang University (CN), Huazhong University of Science and Technology (CN)
Good health and well-being
Openalex Percentile: Top 19%
CAR-T cell therapy research
1.05
DOIOpen Access PDFOpenAlex
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