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Best practices for the development, analytical validation and clinical implementation of flow cytometric methods for chimeric antigen receptor T cell analyses
Author(s) -
Sarikonda Ghanashyam,
Mathieu Mélissa,
Natalia Mahwish,
Pahuja Anil,
Xue Qiong,
Pierog Piotr L.,
Trampont Paul C.,
Decman Vilma,
Reynolds Susan,
Hanafi LaïlaAïcha,
Sun Yongliang S.,
Eck Steven,
Hedrick Michael N.,
Stewart Jennifer J.,
Tangri Shabnam,
Litwin Virginia,
Dakappagari Naveen
Publication year - 2021
Publication title -
cytometry part b: clinical cytometry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.646
H-Index - 61
eISSN - 1552-4957
pISSN - 1552-4949
DOI - 10.1002/cyto.b.21985
Subject(s) - chimeric antigen receptor , reimbursement , flow cytometry , clinical trial , new product development , medicine , computer science , computational biology , immunology , immunotherapy , cancer , biology , business , health care , marketing , economics , economic growth
Chimeric Antigen Receptor (CAR) T cells are recognized as efficacious therapies with demonstrated ability to produce durable responses in blood cancer patients. Regulatory approvals and acceptance of these unique therapies by patients and reimbursement agencies have led to a significant increase in the number of next generation CAR T clinical trials. Flow cytometry is a powerful tool for comprehensive profiling of individual CAR T cells at multiple stages of clinical development, from product characterization during manufacturing to longitudinal evaluation of the infused product in patients. There are unique challenges with regard to the development and validation of flow cytometric methods for CAR T cells; moreover, the assay requirements for manufacturing and clinical monitoring differ. Based on the collective experience of the authors, this recommendation paper aims to review these challenges and present approaches to address them. The discussion focuses on describing key considerations for the design, optimization, validation and implementation of flow cytometric methods during the clinical development of CAR T cell therapies.