A feasibility and safety study of a new CD19-directed fast CAR-T therapy for refractory and relapsed B cell acute lymphoblastic leukemia
Abstract
Introduction CD19-targeting chimeric antigen receptor (CAR) T cell therapy has demonstrated high success; however, its therapeutic potential can still be further improved. In addition, the high cost and lengthy process of CAR-T production limit its broad application. We have developed a new platform termed FasT (F) CAR-T with shortened manufacturing time to one day (plus 7 days of additional testing for regulatory requirements). Here we report results from a pre-clinical study of FasT (F) CAR-T (GC007F) and a phase Ⅰ clinical trial to assess the safety and feasibility of treating patients with CD19+ relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). Methods In this study, a second generation of CD19-directed CAR-T was manufactured using the FasT CAR-T platform. Peripheral blood (PB) mononuclear cells were obtained by leukapheresis either from healthy donors for the pre-clinical study or from patients undergoing the clinical trial. T cells were separated and used for CAR-T generation. A xenograft mouse model was used to determine the efficacy of GC007F in vivo. Conventional (C) CAR-T derived from the same healthy donor were also made and tested in parallel for comparison. Between Feb. 2019 and July 2019, 10 adolescent and adult patients with CD19+ relapsed/refractory B-ALL were enrolled in a feasibility trial for CD19 FasT CAR-T (www.clinicaltrials.gov, NCT03825718). FasT CAR-T cells for all patients were successfully manufactured. All patients received a conditi…
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An automated QC testing setup that produces real-time measurements of cell binding and killing may prove advantageous for continuous product quality monitoring during manufacturing.
“An automated QC testing setup that produces real-time measurements of cell binding and killing allowing for continuous product quality monitoring during the manufacturing process, may prove advantageous (125).”
From Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy (2021) · cites this paper as [125]
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Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy
Abou-el-Enein, M., Elsallab, M., Feldman, S. A., Fesnak, A. D., Heslop, H. E., Marks, P., Till, B. G., Bauer, G., & Savoldo, B. (2021) · Blood Cancer Discovery · doi:10.1158/2643-3230.bcd-21-0084 · Cited by 321 · see citing works
- Authors
- Yang, J., He, J., Zhang, X., Wang, Z., Zhang, Y., Cai, S., Sun, Z., Ye, X., He, Y., Shen, L., He, J., Zhang, G., Song, D., Zhang, M., Hu, X., Li, J., Xia, S., Xu, L., Cao, W., & Lu, P.
- Affiliations
- Beijing Dao Pei Hospital (CN)
- Hebei Yanda Ludaopei Hospital (CN)
- Gracell Biotech Co., Ltd, Shanghai, China
- ORCID
- Venue
- Blood
- Publisher
- American Society of Hematology
- Published
- 2019-11-13
- Volume
- 134
- Issue
- Supplement_1
- Pages
- 825-825
- ISSN
- 0006-4971 (ISSN-L)
- 1528-0020
- OpenAlex
- W2991191951
- Cited by
- 20
- References
- 0
- Citations by year
- 2026: 2 · 2024: 1 · 2023: 3 · 2022: 7 · 2021: 5 · 2020: 2
- Type
- conference abstract
- Language
- en
- Open access
- closed
- Locations
- Blood (publishedVersion)
- Topics
- Health Sciences › Medicine › Oncology › CAR-T cell therapy research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Acute Lymphoblastic Leukemia research
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Keywords
- CD19, chimeric antigen receptor T cells, CAR T-cell therapy, relapsed/refractory B-cell acute lymphoblastic leukemia, second-generation CAR, xenograft mouse model, fludarabine and cyclophosphamide conditioning, CAR T cell persistence, CAR T-cell toxicity
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