# Safety and efficacy of a new academic CD19-directed CAR-T cell for refractory/relapsed non-Hodgkin lymphoma and acute lymphoblastic leukemia in Brazil

Source: https://onco.cc/key-papers/paper-donadel-academic-cart19-brazil-bmt-2024/  
OnCo record `paper-donadel-academic-cart19-brazil-bmt-2024` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first report of people in Brazil treated with a CAR-T cell therapy made entirely in a Brazilian public university, for leukaemia and lymphoma that had come back or stopped responding.

## Summary

A two-centre retrospective report, published as a letter, from the Hospital das Clínicas de Ribeirão Preto and the Hospital das Clínicas de São Paulo (University of São Paulo). Twenty patients with relapsed or refractory B-cell non-Hodgkin lymphoma (7) or B-cell acute lymphoblastic leukaemia (13) were treated between 2019 and 2023 with an academic CD19-directed CAR-T product (HD37 clone, 4-1BB costimulatory domain). Lymphocytes were collected by apheresis, selected, activated, transduced and expanded, cryopreserved, and infused after lymphodepletion. The authors evaluated cytokine release syndrome, neurotoxicity (ICANS), cytopenias and response.

## Fields

- Kind: Key paper
- Last checked: 2026-11-03
- Journal: Bone Marrow Transplantation
- Year: 2024
- DOI: 10.1038/s41409-024-02283-6
- Authors: Donadel CD, De Santis GC, Gonçalves TE, Pires BG, Palma LC, Gava F, Guerino-Cunha RL, Faria JTB, Silva GVA, Darrigo-Junior LG, Fatobene G, Rocha V, Covas DT, Calado RT, Clé DV
- Findings: 20 patients treated, 13 with B-cell acute lymphoblastic leukaemia and 7 with B-cell non-Hodgkin lymphoma, from 2019 to 2023.; The authors note that commercial CAR-T cell products are expensive, which has fostered alternative manufacturing such as this academic product.
- What it means: It is the evidence base for CARTHEDRALL, the multicentre trial meant to bring a national CAR-T to Brazil's public health system at a fraction of the price of imported products.
- Caveats: Retrospective, small and not randomised; response and toxicity rates are in the paywalled full text and are not repeated here.; Patients were treated outside a formal trial; the prospective test is NCT06101381.

## Sources

- DOI: 10.1038/s41409-024-02283-6: https://doi.org/10.1038/s41409-024-02283-6

## Connected records

- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/)
- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/)
- targets: [CD19](https://onco.cc/targets/cd19/)
- institutions: [Fundação Hemocentro de Ribeirão Preto](https://onco.cc/institutions/hemocentro-ribeirao-preto/)
- trials: [CD19-directed CAR-T cell therapy for refractory or relapsed acute lymphoblastic leukaemia or non-Hodgkin lymphoma (CARTHEDRALL)](https://onco.cc/trials/nct06101381/)
- people: [Diego Villa Clé](https://onco.cc/people/diego-villa-cle/), [Rodrigo Calado](https://onco.cc/people/rodrigo-calado/)

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