Novel CD19 Fast-CAR-T cells vs. CD19 conventional CAR-T cells for the treatment of relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia.

Xu TAN; Jishi WANG; Shangjun CHEN; Li LIU; Yuhua LI; Sanfang TU; Hai YI; Jian ZHOU; Sanbin WANG; Ligen LIU; Jian GE; Yongxian HU; Xiaoqi WANG; Lu WANG; Guo CHEN; Han YAO; Cheng ZHANG; Xi ZHANG

Return

Novel CD19 Fast-CAR-T cells vs. CD19 conventional CAR-T cells for the treatment of relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia.

Author: Xu TAN ¹ ; Jishi WANG ² ; Shangjun CHEN ³ ; Li LIU ⁴ ; Yuhua LI ⁵ ; Sanfang TU ⁵ ; Hai YI ⁶ ; Jian ZHOU ⁷ ; Sanbin WANG ⁸ ; Ligen LIU ⁹ ; Jian GE ¹⁰ ; Yongxian HU ¹¹ ; Xiaoqi WANG ¹ ; Lu WANG ¹ ; Guo CHEN ¹ ; Han YAO ¹ ; Cheng ZHANG ¹ ; Xi ZHANG ¹
Author Information

1. Medical Center of Hematology, Xinqiao Hospital of Army Medical University, Chongqing 400037, China.
2. Department of Hematology, The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou 550004, China.
3. Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430032, China.
4. Department of Hematology, Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi 710032, China.
5. Department of Haematology, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, 510260, China.
6. Department of Hematology, The General Hospital of Western Theater Command, PLA, Chengdu, Sichuan 610083, China.
7. Department of Hematology, Henan Cancer Hospital, Zhengzhou, Henan 450008, China.
8. Department of Hematology, 920th Hospital of Joint Logistics Support Force, Kunming, Yunnan 650032, China.
9. Department of Hematology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200240, China.
10. Department of Hematology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230022, China.
11. Bone Marrow Transplantation Center, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 311100, China.
Publication Type:Journal Article
Keywords: Allo-HSCT; CD19 Fast-CAR-T cells; CD19 conventional CAR-T cells; CD19-positive B-cell ALL; Relapse/refractory
From: Chinese Medical Journal 2025;138(19):2491-2497
CountryChina
Language:English
Abstract: BACKGROUND:Treatment with chimeric antigen receptor-T (CAR-T) cells has shown promising effectiveness in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), although the process of preparing for this therapy usually takes a long time. We have recently created CD19 Fast-CAR-T (F-CAR-T) cells, which can be produced within a single day. The objective of this study was to evaluate and contrast the effectiveness and safety of CD19 F-CAR-T cells with those of CD19 conventional CAR-T cells in the management of R/R B-ALL.
METHODS:A multicenter, retrospective analysis of the clinical data of 44 patients with R/R B-ALL was conducted. Overall, 23 patients were administered with innovative CD19 F-CAR-T cells (F-CAR-T group), whereas 21 patients were given CD19 conventional CAR-T cells (C-CAR-T group). We compared the rates of complete remission (CR), minimal residual disease (MRD)-negative CR, leukemia-free survival (LFS), overall survival (OS), and the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) between the two groups.
RESULTS:Compared with the C-CAR-T group, the F-CAR-T group had significantly higher CR and MRD-negative rates (95.7% and 91.3%, respectively; 71.4% and 66.7%, respectively; P = 0.036 and P = 0.044). No significant differences were observed in the 1-year or 2-year LFS or OS rates between the two groups: the 1-year and 2-year LFS for the F-CAR-T group vs.C-CAR-T group were 47.8% and 43.5% vs. 38.1% and 23.8% (P = 0.384 and P = 0.216), while the 1-year and 2-year OS rates were 65.2% and 56.5% vs. 52.4% and 47.6% (P = 0.395 and P = 0.540). Additionally, among CR patients who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) following CAR-T-cell therapy, there were no significant differences in the 1-year or 2-year LFS or OS rates: 57.1% and 50.0% vs. 47.8% and 34.8% (P = 0.506 and P = 0.356), 64.3% and 57.1% vs. 65.2% and 56.5% (P = 0.985 and P = 0.883), respectively. The incidence of CRS was greater in the F-CAR-T group (91.3%) than in the C-CAR-T group (66.7%) (P = 0.044). The incidence of ICANS was also greater in the F-CAR-T group (30.4%) than in the C-CAR-T group (9.5%) (P = 0.085), but no treatment-related deaths occurred in the two groups.
CONCLUSION:Compared with C-CAR-T-cell therapy, F-CAR-T-cell therapy has a superior remission rate but also leads to a tolerably increased incidence of CRS/ICANS. Further research is needed to explore the function of allo-HSCT as an intermediary therapy after CAR-T-cell therapy.