The European ARI-chALL project, coordinated by the SJD Hospital, is promoting a new clinical trial in pediatric leukemia

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

Acute lymphoblastic leukemia is the most common childhood cancer 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 abnormalities. In these cases, new, more effective and less toxic therapeutic alternatives are needed.

CAR-T technology developed in Europe

The CAR-T ARI-0001 therapy was developed by Dr Manel Juan at Hospital Clinic Barcelona, in collaboration with the SJD Barcelona Children's Hospital for pediatric applications. It is the first CAR-T developed entirely in academia in Europe and it is authorised for use in Spain by the Spanish Agency of Medicines and Medical Devices under the Hospital Exemption Clause for adults with refractory or relapsed ALL.

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

'Acute lymphoblastic leukemia is now a highly curable cancer in most children, but when the first relapse significantly worsens prognosis', explains Dr Susana Rives, principal investigator of the project and Pediatric Hematologist at the SJD Barcelona Children's Hospital. She adds: 'With this clinical trial, we want to offer a new therapeutic opportunity to these patients, evaluating the effectiveness and safety of CAR-T ARI-0001 in the pediatric age group, and moving towards more personalised, effective and less toxic treatments'.

Driven by European foundations

The ARI-chALL trial is part of the ATTRACT 2025 research call for proposals, promoted by six European cancer charities that have joined forces to bolster 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 (The Netherlands) and, in this new edition, the Rising Tide Foundation for Clinical Cancer Research (Switzerland).

In Spain, the study was also awarded €200,000 worth of funding by the Bosch Aymerich Foundation, 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 Pediatric 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 ARI-chALL, SJD Barcelona Children's Hospital is strengthening its leadership in clinical research and innovation in pediatric oncology to respond to medical needs that are not yet being met.