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Abstract Number: L17

Allogenic CD19 CAR NK Cells Therapy in Refractory Systemic Lupus Erythematosus: An Open-label, Single Arm, Prospective and Interventional Clinical Trial

Yiyi Yu1, Ruina Kong1, Xia Xu1, Suxuan Liu1, Qian Chen1, Xiaofang Li2, Ming Sun2, Jianmin Yang1, Dongbao Zhao1 and Jie Gao1, 1Changhai Hospital, Shanghai, China, 2Rui Therapeutics, Nanjing, China

Meeting: ACR Convergence 2024

Date of first publication: October 24, 2024

Keywords: B-Cell Targets, Late-Breaking 2024, Natural Killer Cells, Systemic lupus erythematosus (SLE)

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Session Information

Date: Tuesday, November 19, 2024

Title: Late-Breaking Abstracts (L15–L20)

Session Type: Late-Breaking Abstracts

Session Time: 8:00AM-9:30AM

Background/Purpose: Treatment of systemic lupus erythematosus (SLE) typically necessitates long-term immunosuppression with hormones, immunosuppressants and biologics. CD19-targeting chimeric antigen receptor (CAR) T cells have shown excellent efficacy in a variety of autoimmune diseases including SLE, indicating that reset of aberrant autoimmunity via deep B-cell depletion is a promising strategy for achieving sustained long-lasting remission.

Methods: We evaluated 20 patients with active severe and refractory SLE that received 3 does infusion of allogenic CD19-targeting CAR-nature killing (NK) cells after preconditioning with cyclophosphamide and fludarabine. Long-term efficacy up to 12 months after CAR-NK cells infusion was assessed by utilizing the criteria of lupus low disease activity state (LLDAS) and the 2021 DORIS (definition of remission in SLE) definition of remission in SLE. Short- and long-term safety concerned adverse events including the cytokine release syndrome and infections were monitored.

Results: The median disease duration is 10 years (from 1 to 17 years). 1 patient received does level (DL), 1 patient received DL2, 5 patients received DL3, and 13 patients received DL4 CAR-NK cells infusion. The median follow-up was 5 months (range, 1 to 12). Reconstitution of B cells was observed in 2 to 3 months post CAR-NK cells therapy. Grade 1 cytokine release syndrome (fever only for a short of time) occurred in 2 patients, no other adverse events and infections were observed during and post the CAR-NK cells treatment. Of the 8 patients with more than 6 months of follow-up, 50.0 % (4/8) achieved DORIS remission and 75.0% (6/8) achieved LLDAS.

Conclusion: In this study, allogeneic CD19-targeting CAR-NK cell therapy for SLE exhibited excellent safety and could also achieve rapid and long-lasting remission of relapsed and refractory SLE, which will be a promising off-shelf and universal cell therapy for patients with SLE.


Disclosures: Y. Yu: None; R. Kong: None; X. Xu: None; S. Liu: None; Q. Chen: None; X. Li: None; M. Sun: None; J. Yang: None; D. Zhao: None; J. Gao: None.

To cite this abstract in AMA style:

Yu Y, Kong R, Xu X, Liu S, Chen Q, Li X, Sun M, Yang J, Zhao D, Gao J. Allogenic CD19 CAR NK Cells Therapy in Refractory Systemic Lupus Erythematosus: An Open-label, Single Arm, Prospective and Interventional Clinical Trial [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/allogenic-cd19-car-nk-cells-therapy-in-refractory-systemic-lupus-erythematosus-an-open-label-single-arm-prospective-and-interventional-clinical-trial/. Accessed .
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