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Built the manufacturing that turned CAR-T from a lab idea into a product given to thousands of patients.
Bruce L. Levine is the Barbara and Edward Netter Professor in Cancer Gene Therapy and Founding Director of the Clinical Cell and Vaccine Production Facility at the Abramson Cancer Center, University of Pennsylvania. He is known for building the manufacturing that turned CAR-T from a laboratory idea into a product given to thousands of patients, including co-developing the CTL019 manufacturing process. His selected paper reviews global manufacturing of CAR T cell therapy. He is a past president of the International Society for Cell & Gene Therapy and continues to work on cell therapy manufacturing and in vivo CAR-T.
| Title | Journal | Year |
|---|---|---|
| Global manufacturing of CAR T cell therapy | Molecular Therapy Methods & Clinical Development | 2017 |
| ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL | New England Journal of Medicine | 2018 |
| Maude 2014: CD19 CAR-T cells produce complete remission in 27 of 30 children and adults with relapsed ALL | New England Journal of Medicine | 2014 |
ELIANA turned CAR-T from a single-centre experiment into a licensed product and created the regulatory and logistical template every later cell therapy has followed. For children with refractory leukaemia it offers a chance of durable remission without transplant. The trial also exposed the gaps: manufacturing failures, patients dying while waiting, and roughly half relapsing within a few years.
This paper is the proof-of-concept for a living drug: a single infusion of a patient's own engineered T cells could eradicate leukaemia that had survived chemotherapy, transplant and antibody therapy. It defined cytokine release syndrome and its antidote, tocilizumab, and revealed antigen-loss relapse. It led directly to the first approved gene-modified cell therapy three years later.
Shares Emily Whitehead, Maude 2014: CD19 CAR-T cells produce complete remission in 27 of 30 children and adults with relapsed ALL, Abramson Cancer Center, University of Pennsylvania, CAR-T cell therapy.
Shares Maude 2014: CD19 CAR-T cells produce complete remission in 27 of 30 children and adults with relapsed ALL, ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL, Abramson Cancer Center, University of Pennsylvania, CAR-T cell therapy.
Shares Emily Whitehead, Maude 2014: CD19 CAR-T cells produce complete remission in 27 of 30 children and adults with relapsed ALL, ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL, Abramson Cancer Center, University of Pennsylvania.
Shares Emily Whitehead, Abramson Cancer Center, University of Pennsylvania, CAR-T cell therapy.
Shares In vivo CAR-T, Abramson Cancer Center, University of Pennsylvania.
Shares In vivo CAR-T, CAR-T cell therapy.
Shares Emily Whitehead, ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL, CAR-T cell therapy.
Shares In vivo CAR-T, Abramson Cancer Center, University of Pennsylvania.