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Clinical Trial
. 2023 Dec;64(12):1956-1963.
doi: 10.1080/10428194.2023.2246611. Epub 2023 Aug 11.

Point-of-care anti-CD19 chimeric antigen receptor T-cell therapy for relapsed/refractory follicular lymphoma

Shalev Fried  1   2 , Eden Shkury  1   2 , Orit Itzhaki  3 , Inbal Sdayoor  1   2 , Ronit Yerushalmi  1   2 , Noga Shem-Tov  1   2 , Ivetta Danylesko  1   2 , Elad Jacoby  2   4 , Roni Shouval  2   5   6 , Meirav Kedmi  1   2   7 , Ronit Marcus  1 , Arnon Nagler  1   2 , Avichai Shimoni  1   2 , Abraham Avigdor  1   2
Affiliations
Clinical Trial

Point-of-care anti-CD19 chimeric antigen receptor T-cell therapy for relapsed/refractory follicular lymphoma

Shalev Fried et al. Leuk Lymphoma. 2023 Dec.

Abstract

Patients with relapsed/refractory follicular lymphoma (R/R-FL) often require multiple treatment lines. We performed a phase 1b/2 single-center clinical trial of autologous point-of-care anti-CD19 chimeric antigen receptor (CAR) T-cells in R/R-FL patients treated patients with ≥ 2 treatment lines. All 26 patients enrolled received CAR T-cell infusion at a median of 11 days after leukapheresis. Seventy-seven percent of patients had POD24. At enrollment, disease stage was III-IV in 85% of the patients, 77% had high-risk FLIPI score, and 77% had progressive disease. Grade III-IV cytokine release and immune effector cell-associated neurotoxicity syndromes occurred in 12% and 16% of the patients, respectively. Overall response rate at 1-month was 88%. The median follow-up was 15.4 months. One-year overall and progression-free survival were 100% and 63%, respectively. In conclusion, point-of-care CAR T-cell, manufactured within 11 days, induced a high response rate with an acceptable safety profile in patients with high-risk R/R-FL.

Keywords: Chimeric antigen receptor; follicular lymphoma; point-of-care.

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Conflict of interest statement

Conflict of interest statement: The authors report there are no competing interests to declare.

Disclosure of interest: R.S served as a consultant for Medexus and MyBiotics. A.S served on scientific advisory board for Jazz, Gilead, Novartis, Abbvie, Bristol-Myers Squibb and Medac. A.A reports honoraria from Abbvie and served as a member of advisory board of Takeda, Gilead, Novartis, Roche and Bristol-Myers Squibb.

Figures

Figure 1.
Figure 1.. Alluvial plot showing 1-month disease response rate in follicular lymphoma patients treated with point-of-care CAR-T cell therapy.
Abbreviations: CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease.
Figure 2.
Figure 2.. Kaplan-Meier curves of patients who received point-of-care CAR T-cell therapy.
A, overall survival; B, progression-free survival; and C, duration of response.
See this image and copyright information in PMC

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