Long-term follow-up of third generation anti-CD30 CAR T-cell therapy in relapsed/refractory CD30+ lymphomas: a single-arm, multicentre, phase 1-2 trial

Abstract Purpose: This report presents long-term outcomes of third-generation anti-CD30 CAR T-cell therapy in relapsed/refractory (r/r) CD30+ lymphoma patients. Patients and Methods: In this single-arm, multicentre, phase 1/2 trial, patients received lymphodepletion regimen comprising fludarabine and cyclophosphamide, followed by infusion of anti-CD30 CAR-T cells. Primary endpoints included safety and overall response rate (ORR), while secondary endpoints were progression-free survival (PFS) and overall survival (OS). Results: Forty-four patients were enrolled, including 33 cases of Hodgkin lymphoma. Of 44 patients, 23 achieved complete response (CR) to CAR-T, and 19 achieved PR, resulting in a CR rate of 52.3% and an ORR of 95.5%. The most frequent toxicities were hematologic AEs of grade 3 or higher (68.2% of neutropenia). Cytokine release syndrome occurred in 18 patients (40.9%), with two cases (4.5%) being ≥ grade 3. In the follow-up period, 24 patients underwent auto-HSCT after CAR-T within a median of 3 months. The best ORR was 95.5%, with 27 patients (61.4%) achieving CR. The best CR rate was higher in patients receiving CAR-T followed by auto-HSCT compared to those receiving CAR-T alone (75% vs. 45%). 3-year OS and PFS rates for all patients were 79.0% (95%CI, 66.1%–91.9%) and 74.2% (95%CI, 60.3% –88.1%). Patients receiving consolidated auto-HSCT following CAR-T exhibited significantly longer OS and PFS compared to those treated with CAR-T alone. Conclusion: Third-generation anti-CD30 CAR-T demonstrates high efficacy and a favorable safety profile in r/r CD30+ lymphoma patients. Addition of auto-HSCT following CAR T-cell therapy improves depth of remission and potentially enhances OS and PFS.

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Journal
Clinical Cancer Research
Published
2026-07-22
DOI
https://doi.org/10.1158/1078-0432.ccr-26-1292
Primary Topic
CAR-T cell therapy research
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article
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article

Long-term follow-up of third generation anti-CD30 CAR T-cell therapy in relapsed/refractory CD30+ lymphomas: a single-arm, multicentre, phase 1-2 trial

Tongcun Zhang, Qingyun Wu, Wei Sang, Caixia Li et al.
Clinical Cancer Research
CAR-T cell therapy research
article

Long-term follow-up of third generation anti-CD30 CAR T-cell therapy in relapsed/refractory CD30+ lymphomas: a single-arm, multicentre, phase 1-2 trial

Tongcun Zhang, Qingyun Wu, Wei Sang, Caixia Li, Liang Huang, Linyan Xu, Xiangmin Wang, Ziyuan Shen, Ting Niu, Yicheng Zhang, Wenbin Qian, Hongzhi Geng, Jiaoli Zhang, Kang Rong, Han Sun, Yawen Wei, Xicheng Chen, Ruiyang Xie, Jiahui Sun, Peiling Zhang, Dongmei Yan, Meina Zhang, Hongyuan Zhou, Yujie Li, Qing Zhang, Tianci Li
article en

Abstract

Abstract Purpose: This report presents long-term outcomes of third-generation anti-CD30 CAR T-cell therapy in relapsed/refractory (r/r) CD30+ lymphoma patients. Patients and Methods: In this single-arm, multicentre, phase 1/2 trial, patients received lymphodepletion regimen comprising fludarabine and cyclophosphamide, followed by infusion of anti-CD30 CAR-T cells. Primary endpoints included safety and overall response rate (ORR), while secondary endpoints were progression-free survival (PFS) and overall survival (OS). Results: Forty-four patients were enrolled, including 33 cases of Hodgkin lymphoma. Of 44 patients, 23 achieved complete response (CR) to CAR-T, and 19 achieved PR, resulting in a CR rate of 52.3% and an ORR of 95.5%. The most frequent toxicities were hematologic AEs of grade 3 or higher (68.2% of neutropenia). Cytokine release syndrome occurred in 18 patients (40.9%), with two cases (4.5%) being ≥ grade 3. In the follow-up period, 24 patients underwent auto-HSCT after CAR-T within a median of 3 months. The best ORR was 95.5%, with 27 patients (61.4%) achieving CR. The best CR rate was higher in patients receiving CAR-T followed by auto-HSCT compared to those receiving CAR-T alone (75% vs. 45%). 3-year OS and PFS rates for all patients were 79.0% (95%CI, 66.1%–91.9%) and 74.2% (95%CI, 60.3% –88.1%). Patients receiving consolidated auto-HSCT following CAR-T exhibited significantly longer OS and PFS compared to those treated with CAR-T alone. Conclusion: Third-generation anti-CD30 CAR-T demonstrates high efficacy and a favorable safety profile in r/r CD30+ lymphoma patients. Addition of auto-HSCT following CAR T-cell therapy improves depth of remission and potentially enhances OS and PFS.

Clinical Cancer Research
Xuzhou Medical College (CN), Wuhan University of Technology (CN), Sichuan University (CN), Soochow University (CN), West China Hospital of Sichuan University (CN), Affiliated Hospital of Xuzhou Medical College (CN), Institute of Hematology & Blood Diseases Hospital (CN), First Affiliated Hospital of Soochow University (CN), Second Affiliated Hospital of Zhejiang University (CN), Tongji Hospital (CN), Wuhan University of Science and Technology (CN)
Good health and well-being
Openalex Percentile: Top 11%
CAR-T cell therapy research
DOISourceOpenAlex
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