Authors: | Fried, S.; Shkury, E.; Itzhaki, O.; Sdayoor, I.; Yerushalmi, R.; Shem-Tov, N.; Danylesko, I.; Jacoby, E.; Shouval, R.; Kedmi, M.; Marcus, R.; Nagler, A.; Shimoni, A.; Avigdor, A. |
Article Title: | Point-of-care anti-CD19 chimeric antigen receptor T-cell therapy for relapsed/refractory follicular lymphoma |
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. © 2023 Informa UK Limited, trading as Taylor & Francis Group. |
Keywords: | adult; clinical article; aged; middle aged; overall survival; fludarabine; clinical trial; rituximab; neurotoxicity; follow up; progression free survival; phase 2 clinical trial; anemia; point-of-care systems; thrombocytopenia; relapse; aciclovir; bendamustine; cyclophosphamide; immunoglobulin; recurrent infection; risk factor; febrile neutropenia; thorax pain; chimeric antigen receptor; effector cell; bacteremia; virus infection; phase 1 clinical trial; kaplan meier method; biological therapy; anticonvulsive agent; corticosteroid; cotrimoxazole; immunoglobulin deficiency; tumor classification; follicular lymphoma; lymphoma, follicular; disease exacerbation; cytomegalovirus infection; adoptive immunotherapy; immunotherapy, adoptive; cd19 antigen; antigens, cd19; leukapheresis; clinical outcome; cytokine release syndrome; overall response rate; tocilizumab; escherichia coli infection; cd19 antibody; humans; human; male; female; article; cell- and tissue-based therapy; point-of-care; infusion therapy; chimeric antigen receptor t-cell immunotherapy; coronavirus disease 2019; receptors, chimeric antigen; immune effector cell-associated neurotoxicity syndrome; refractory tumor; pseudomonas pneumonia |
Journal Title: | Leukemia and Lymphoma |
Volume: | 64 |
Issue: | 12 |
ISSN: | 1042-8194 |
Publisher: | Taylor & Francis Group |
Date Published: | 2023-01-01 |
Start Page: | 1956 |
End Page: | 1963 |
Language: | English |
DOI: | 10.1080/10428194.2023.2246611 |
PUBMED: | 37565578 |
PROVIDER: | scopus |
PMCID: | PMC11023741 |
DOI/URL: | |
Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PDF -- Source: Scopus |