The European ARIchALL project, coordinated by SJD Hospital, is promoting a new clinical trial in paediatric leukaemia

SJD Barcelona Children's Hospital is the coordinating centre for the European project ARIchALL (ARI childhood Acute Lymphoblastic Leukaemia), an international initiative promoting a new clinical trial for children with acute lymphoblastic leukaemia (ALL) in first relapse using CAR-T ARI-0001 therapy.

Acute lymphoblastic leukaemia is the most common cancer in childhood and affects lymphocytes, a type of white blood cell. Although current treatments can cure between 80 and 90% of cases, the prognosis worsens significantly when a first relapse occurs, especially if it is early or associated with certain genetic alterations. In these cases, new, more effective and less toxic therapeutic alternatives are needed.

A CAR-T developed in Europe

The CAR-T ARI-0001 therapy was developed by Dr Manel Juan at the Hospital Clínic de Barcelona, with the collaboration of SJD Hospital in the paediatric field. It is the first CAR-T developed entirely in academia in Europe and authorised in Spain by the Spanish Agency for Medicines and Health Products under the Hospital Exemption Clause for adults with refractory or relapsed ALL.

In 2023, SJD Barcelona Children's Hospital was able to start a clinical trial thanks to funding from a grant from Instituto de Salud Carlos III and a donation from Ariana Benedé's family, a patient initially treated at the centre and later at the Hospital Clínic after a relapse. Since then, the hospital has had 30 paediatric patients who are already in phase 2 of the trial. With the ARIchALL project, 10 more children from Spain are being added, bringing the total to 40. Overall, the study will include 70 children from various European countries, all in first relapse. CAR-T ARI-0001 is already being manufactured at the Advanced Therapies Platform at SJD.

"Acute lymphoblastic leukaemia is now a highly curable cancer in most children, but when a first relapse occurs, the prognosis worsens significantly," explains Dr Susana Rives, principal investigator of the project and paediatric haematologist at SJD Hospital. She adds: "With this clinical trial, we want to offer a new therapeutic opportunity to these patients, evaluating the efficacy and safety of CAR-T ARI-0001 in the paediatric population and moving towards more personalised, effective and less toxic treatments."

The impetus of European foundations

The ARIchALL trial is part of the ATTRACT 2025 call for proposals, promoted by six European cancer charities that have joined forces to stimulate international research into the treatment of rare cancers. The promoters are the Anticancer Fund (Belgium), the Spanish Association Against Cancer (Spain), Fondation ARC (France), Kom op tegen Kanker/Kom Cancer Society (Netherlands) and, in this new edition, the Rising Tide Foundation for Clinical Cancer Research (Switzerland).

In Spain, the study is also funded by the Bosch Aymerich Foundation with €200,000, which will allow the number of participants to be increased by three more patients.

The trial, led by the SJD Clinical Research Unit, aims to expand the clinical evidence needed to meet the requirements of the European Medicines Agency under the Paediatric Investigation Plan (PIP).

One of the milestones of the project will be the manufacture of CAR-T ARI-0001 in hospitals in other participating countries, creating a European network of centres producing advanced therapies. With the coordination of ARIchALL, SJD Barcelona Children's Hospital is strengthening its leadership in clinical research and innovation in paediatric oncology to respond to medical needs that are not yet being met.