# CART19-BE-01 (ARI-0001 CAR-T, Hospital Clínic de Barcelona)

Source: https://onco.cc/trials/cart19-be-01/  
OnCo record `cart19-be-01` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The academic trial at Hospital Clínic and Sant Joan de Déu in Barcelona that tested a CAR-T cell therapy made in the hospital itself, and led to Spain authorising it in 2021.

## Summary

CART19-BE-01 tested ARI-0001, a CD19-directed CAR-T cell product with 4-1BB and CD3-zeta signalling designed and manufactured at Hospital Clínic de Barcelona, in adults and children with relapsed or refractory CD19-positive leukaemia or lymphoma. Patients received cyclophosphamide and fludarabine and then ARI-0001 cells, at first as a single dose and, after a protocol amendment, split into three fractions (10%, 30% and 60%) with the full dose given only in the absence of cytokine release syndrome.

In the 2021 report in Molecular Therapy, 58 patients were included and 47 treated: 38 with acute lymphoblastic leukaemia, 8 with non-Hodgkin lymphoma and 1 with chronic lymphocytic leukaemia. In acute lymphoblastic leukaemia, grade 3 or higher cytokine release syndrome occurred in 13.2% (26.7% before the amendment against 4.3% after), and the measurable residual disease-negative complete response rate at day 100 was 71.1%. The registry lists 50 participants and completion on 13 September 2022. On these results the AEMPS authorised ARI-0001 under the hospital exemption in February 2021 for adults over 25 with relapsed or refractory acute lymphoblastic leukaemia.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-11-03
- Also known as: CART19-BE-01; ARI-0001 pilot study
- Registry id: NCT03144583
- Phase: 1
- Setting: Pilot Study on the Infusion of ARI-0001 Cells in Patients With CD19+ Leukemia or Lymphoma Refractory to Therapy
- Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), with the Instituto de Salud Carlos III
- Enrolled: 50
- Result: Measurable residual disease-negative complete response at day 100 in 71.1% of patients with acute lymphoblastic leukaemia; one-year overall survival 68.6% (Mol Ther 2021).

## Sources

- ClinicalTrials.gov NCT03144583: https://clinicaltrials.gov/study/NCT03144583
- Ortíz-Maldonado et al., Mol Ther 2021: https://doi.org/10.1016/j.ymthe.2020.09.027
- PubMed: https://pubmed.ncbi.nlm.nih.gov/33010231/

## Connected records

- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [Chronic lymphocytic leukaemia](https://onco.cc/cancers/cll/), [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/)
- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/), [Point-of-care and decentralised cell manufacturing](https://onco.cc/technologies/point-of-care-cell-manufacturing/)
- targets: [CD19](https://onco.cc/targets/cd19/)
- drugs: [Varnimcabtagene autoleucel](https://onco.cc/drugs/varnimcabtagene-autoleucel/)
- institutions: [Hospital Clínic de Barcelona / IDIBAPS](https://onco.cc/institutions/hospital-clinic-barcelona/), [Instituto de Salud Carlos III (ISCIII)](https://onco.cc/institutions/isciii/)
- terms: [Cytokine release syndrome (CRS)](https://onco.cc/terms/crs/), [ICANS (neurotoxicity)](https://onco.cc/terms/icans/)
- people: [Julio Delgado](https://onco.cc/people/julio-delgado/), [Manel Juan](https://onco.cc/people/manel-juan/), [Valentín Ortiz-Maldonado](https://onco.cc/people/valentin-ortiz-maldonado/)
- key papers: [CART19-BE-01: A Multicenter Trial of ARI-0001 Cell Therapy in Patients with CD19(+) Relapsed/Refractory Malignancies](https://onco.cc/key-papers/paper-cart19-be-01-mol-ther-2021/), [The hospital exemption pathway for advanced therapies and the case of the CAR-T ARI-0001](https://onco.cc/key-papers/paper-trias-hospital-exemption-ari-0001-bmt-2022/)

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