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Driving the CAR to the Bone Marrow Transplant Program

  • CART and Immunotherapy (M Ruella and P Hanley, Section Editors)
  • Published:
Current Hematologic Malignancy Reports Aims and scope Submit manuscript

Abstract

Purpose of Review

The US Food and Drug Administration (FDA) approved two commercially available chimeric antigen receptor (CAR) T cell therapies for the treatment of relapsed B cell acute lymphoblastic leukemia (B-ALL) children and young adults less than 25 years of age and non-Hodgkin lymphoma in adults after promising results from early-phase single and multi-institutional clinical trials. In this review, we provide an overview of the practical aspects of a chimeric antigen T cell receptor (CAR-T) program development and the steps necessary for its successful implementation.

Recent Findings

CAR-T therapy is a complex process and poses significant challenges as institutions prepare to deliver this therapy as a standard of care for the eligible patients. It requires a rigorous infrastructure with specific clinical, administrative, and regulatory demands. Institutions that led the clinical trials for CAR-T have adopted various approaches to integrate commercial CAR-T products into their program.

Summary

Delivering commercial CAR-T cells outside the scope of clinical trials requires careful planning, allocation of resources, and utilization of existing infrastructure. Institutions may need to adapt the existing recommendations and guidelines and tailor them to meet the needs of their program and ensure appropriate financial reimbursement for this expensive but promising immunotherapy.

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Author information

Authors and Affiliations

  1. Center for Cancer and Immunology Research, Children’s National Health System, Washington, DC, USA

    Hema Dave, Lauren Jerkins, Patrick J Hanley, Catherine M Bollard & David Jacobsohn

  2. The George Washington University School of Medicine and Health Sciences, 111 Michigan Ave NW, Washington, DC, 20010, USA

    Hema Dave, Lauren Jerkins, Catherine M Bollard & David Jacobsohn

  3. Division of Blood and Marrow Transplantation, Center for Cancer and Blood Disorders, Children’s National Health System, Washington, DC, USA

    David Jacobsohn

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  1. Hema Dave
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  2. Lauren Jerkins
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  4. Catherine M Bollard
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  5. David Jacobsohn
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Corresponding author

Correspondence to Hema Dave.

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Conflict of Interest

H. D has received funding from the Lymphoma Research Foundation. L. J, none, D. J, none, P.J.H is a cofounder of Mana Therapeutics and is on the board of directors of Mana Therapeutics, C.M.B. is on the scientific advisory board (SAB) for Cellectis, has stock options in Neximmune, Torque Therapeutics, and Cabaletta Bio and is a cofounder and Scientific Advisory Board member of Mana Therapeutics.

Human and Animal Rights

All reported studies/experiments with human or animal subjects performed by the authors have been previously published and complied with all applicable ethical standards (including the Helsinki declaration and its amendments, institutional/national research committee standards, and international/national/institutional guidelines).

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Dave, H., Jerkins, L., Hanley, P.J. et al. Driving the CAR to the Bone Marrow Transplant Program. Curr Hematol Malig Rep 14, 561–569 (2019). https://doi.org/10.1007/s11899-019-00544-6

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  • DOI: https://doi.org/10.1007/s11899-019-00544-6

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