Treatment at Hospital Clínic

Around 100 CAR-T therapy productions have been carried out in the last year and dozens of commercial CAR-T products have also been infused. This entails monitoring a large number of patients.

After taking the different follow-up samples from the patients, they are sent to the Biomedical Diagnostic Centre (CDB) to be distributed to the different services and laboratories; among which are the Immunotherapy Section, the Pathological Anatomy service and the Haematopathology laboratory.

The Hospital Clínic Barcelona is notable for being a pioneering centre for the production of CAR-T therapies in Spain and also in Europe. Among the most significant milestones is the approval of the pioneering clinical trial for the use of ARI-0001, which was the first CAR-T developed entirely in Europe and approved by a regulatory authority. In addition, the Spanish Agency for Medicines and Medical Devices (AEMPS) approved the hospital exemption for this therapy. This means the advanced therapy is allowed at the national level, without yet having a marketing authorisation.

It was granted the PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA). PRIME is a programme launched by the EMA to support the development of medicines that address a medical need for which there is currently no treatment. The goal is to accelerate evaluation so these medications can reach patients as soon as possible.

Another important milestone is the approval of the clinical trial for the use of ARI-0002h. The first academic multicentre CAR-T therapy clinical trial in Spain.

In addition to these therapies, the first clinical trial against T-cell lymphoblastic leukaemia in the European Union was recently approved, in collaboration with OneChain Immunotherapeutics (a spin-off of the Josep Carreras Foundation against leukaemia). These and many other milestones make the Hospital Clínic Barcelona a reference centre for CAR-T therapy at both a Spanish and European level.

Also, the Hospital Clínic Barcelona currently has the TIL therapy TILS0001 trial approved, and is one of the pioneering centres, at the Spanish and European level, for using this therapy to treat breast cancer. This trial is currently underway with a single patient enrolled and administered without side effects. It is also expected that this type of therapy can be adapted to other types of solid tumours in the future.

Also, TILs were administered within the C-144-01 trial for melanoma patients without selection for reactive TILs.