Ospedale Pediatrico Bambino Gesù (OPBG) plays a pivotal role in the MILenARI project by coordinating the preparation of future international clinical studies.
Ospedale Pediatrico Bambino Gesù (OPBG), a leading Italian paediatric research hospital with extensive experience in CAR‑T pre-clinical development, technology transfer and clinical trials, plays a pivotal role in the MILenARI project by coordinating the preparation of future international clinical studies..
OPBG will oversee the readiness of the centers for activation of a clinical trial intended for Bcp-ALL pediatric patients. The hospital will also guide on the regulatory point of view on submitting ATMP dossiers to national ethics committees and regulatory authorities.
At the technical level, OPBG will establish and validate CAR‑T manufacturing capabilities in Italy, receiving lentiviral vectors and implementing SOPs shared by IDIBAPS and Hospital Clínic in their own GMP system. OPBG teams will undergo training in CAR‑T clinical management and quality control to ensure readiness for trial activation.
With its strong track record in paediatric oncology and immunotherapy, Bambino Gesù’s leadership is key to bringing ARI‑0001 into an international paediatric clinical trial framework, laying the groundwork for broader therapeutic access across the Mediterranean.
Last Update
26/03/2026
Next Med