Clínic Barcelona – IDIBAPS, pioneering hospital in CAR-T therapies for cancer, has treated more than 500 patients

Since May 2017, when the first infusion of a CAR-T treatment was performed, Clínic Barcelona – IDIBAPS has led the development of several innovative immunotherapies. Two of these therapies are already approved by the Spanish Agency for Medicines and Health Products (AEMPS) as advanced therapy drugs of non-industrial manufacture: ARI-0001, indicated for patients with acute lymphoblastic leukaemia, and ARI-0002h, to treat multiplex. Both have demonstrated efficacy and safety in people who did not respond to other treatments.

The development and production of advanced therapies is possible thanks to the involvement of a multidisciplinary team made up of nearly 200 professionals from IDIBAPS, Hospital Clínic and the University of Barcelona.

A statewide network to treat patients with CAR-T ARIs

The administration of CAR-T ARIs was initially carried out through rigorous clinical trials in compliance with the requirements of the AEMPS developed by the Clinical Pharmacology, Immunology and Haematology services of the Hospital Clínic Barcelona.

Having demonstrated the efficacy and safety of the ARIs, their administration to patients is now routine practice in the haematology service of the hospital’s Institute of Cancer and Blood Diseases (ICAMS).

Since the start of the programme in 2017, an increasing number of patients are being treated each year, reaching more than 100 annually. The diseases they have been treated for are acute lymphoblastic leukaemia, multiple myeloma and non-Hodgkin’s lymphoma. Of these more than 500 patients, 70 per cent came from other hospitals in the state.

‘The vast majority of the 502 treatments mentioned were for people with blood cancers resistant to conventional treatments. The ARIs provided hope for life, and many of these patients are now cured,’ explains Dr. Álvaro Urbano-Ispizua.

Bringing treatment closer to the patient

Hospital Clínic Barcelona leads the decentralised production of CAR-T, with the collaboration of 13 Spanish hospitals, bringing the treatment closer to the patients. In this way, the time between apheresis, the first step in the preparation, and the infusion of CAR-T once it has been produced, is shortened. Currently, apart from the Clínic, there are two other centres producing ARI CAR-Ts: the Hospital Sant Joan de Déu in Barcelona and the Clínica Universidad de Navarra.

The production of each CAR-T treatment requires a joint effort of more than 30 professionals specialised in the production of advanced therapies and work in clean rooms. Overall, a single treatment takes 10 days of continuous work by two doctors and three technicians.

‘Each CAR-T produced represents not only a medical advance, but also the dedication, experience and commitment of all the professionals involved,’ stresses Dr. Manel Juan.

Dr. Josep M. Campistol values the fact of having reached 500 patients treated with the CAR-Ts ARI: ‘This achievement positions the Clínic-IDIBAPS as a reference in innovation and academic development of this type of therapies, being the only hospital in Europe that has developed and has two CAR-T therapies for those people who require them anywhere in the territory’.

The future of CAR-T therapies at Clínic-IDIBAPS

Cellular immunotherapy is one of the main lines of research and medical innovation at the Clínic Barcelona Comprehensive Cancer Center of the Fundació la Caixa with the aim of developing new CAR-Ts to treat patients with different types of solid tumours or haematological diseases.

On the other hand, research is also focused on improving the functionality of CAR-Ts once they reach the tumour.

In addition to the two approved CAR-T therapies, the Clínic has launched a new pioneering clinical trial with a new CAR-T for lymphoma, ARI-0003. ‘It is a dual CAR-T and is aimed at two therapeutic targets present in malignant cells: CD-19 and BCMA,’ explains Dr Álvaro Urbano-Ispizua.

A trial will also soon begin with CAR-T HER2 for the treatment of breast cancer and with CAR-T ARI-007 to treat people diagnosed with acute T-lymphoblastic leukaemia.

In addition, the Clínic continues to develop new CAR-Ts in the laboratory, incorporating improvements that significantly increase their efficacy.

The Bosch and Aymerich Foundation and the Spanish Association Against Cancer (AECC) have also collaborated in the development of CAR-Ts at Clínic Barcelona – IDIBAPS, as well as companies and individuals through a large number of donations. Thanks to this support from public institutions and civil society, work is being carried out on the development of new lines of treatment with CAR-Ts.