# The long road to the first FDA-approved gene therapy: chimeric antigen receptor T cells targeting CD19

Source: https://onco.cc/key-papers/paper-cd19-dlbcl-cytotherapy-2020/  
OnCo record `paper-cd19-dlbcl-cytotherapy-2020` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Review on CD19 in Diffuse large B-cell lymphoma, in Cytotherapy (2020), one of the most cited Europe PMC records with CD19 in its title.

## Summary

Thirty years after initial publications of the concept of a chimeric antigen receptor (CAR), the U.S. Food and Drug Administration (FDA) approved the first anti-CD19 CAR T-cell therapy. Unlike other immunotherapies, such as immune checkpoint inhibitors and bispecific antibodies, CAR T cells are unique as they are "living drugs," that is, gene-edited killer cells that can recognize and kill cancer. During these 30 years of development, the CAR construct, T-cell manufacturing process, and clinical patient management have gone through rounds of failures and successes that drove continuous improvement. Tisagenlecleucel was the first gene therapy to receive approval from the FDA for any indication. The initial approval was for relapsed or refractory (r/r) pediatric and young-adult B-cell acute lymphoblastic leukemia in August 2017 and in May 2018 for adult r/r diffuse large B-cell lymphoma. Here we review the preclinical and clinical development of what began as CART19 at the University of Pennsylvania and later developed into tisagenlecleucel.

Indexed on Europe PMC as PubMed record 32014447 (DOI 10.1016/j.jcyt.2019.12.004). Its title names CD19 and its text names Diffuse large B-cell lymphoma; PubMed types it as a review (Research Support, Non-U.S. Gov't, research-article, Review, Research Support, N.I.H., Extramural). It was matched automatically to the idea "In vivo CAR-T as a vial on the shelf: a cost and access trial in lymphoma" and no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: Cytotherapy
- Year: 2020
- DOI: 10.1016/j.jcyt.2019.12.004
- Authors: Braendstrup P, Levine BL, Ruella M
- What it means: One of the most cited reviews Europe PMC returns for CD19 in Diffuse large B-cell lymphoma, so it is a natural first reading for anyone weighing the idea it is linked from. The record was linked automatically by title and abstract; read the abstract above and the paper itself before relying on any figure.
- Caveats: Matched by CD19 in the title and Diffuse large B-cell lymphoma in the title or abstract of the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.; A review summarises other studies; the primary reports it cites are the evidence.

## Sources

- Cytotherapy 2020: https://doi.org/10.1016/j.jcyt.2019.12.004
- PubMed: https://pubmed.ncbi.nlm.nih.gov/32014447/
- Europe PMC: https://europepmc.org/article/MED/32014447

## Connected records

- ideas: [In vivo CAR-T as a vial on the shelf: a cost and access trial in lymphoma](https://onco.cc/ideas/idea-reg-in-vivo-cart-off-the-shelf-vial/), [Non-viral CAR-T (transposon or CRISPR knock-in) as the default manufacturing route](https://onco.cc/ideas/idea-reg-non-viral-cart-manufacturing/)

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