Green light for CAR-T ARI0002h developed by Hospital Clínic-IDIBAPS for patients with multiple myeloma

CAR-T ARI0002h, developed at Hospital Clínic Barcelona-IDIBAPS, has been approved by the Committee for the Evaluation of Medicinal Products for Human Use of the Spanish Agency for Medicines and Health Products (AEMPS) for approval as a non-industrially manufactured advanced therapy medicinal product for patients with relapsed multiple myeloma.

The AEMPS Committee’s approval is the step prior to the notification of the hospital exemption approval that Hospital Clínic Barcelona will receive in the coming days. The approval process from the hospital has been coordinated by the Clinical Pharmacology Service team, led by Dr Gonzalo Calvo.

The development of CAR-T at Hospital Clínic-IDIBAPS has been supported by the Fundació Glòria Soler from its initial stages, and has also received support from the Fundació ‘la Caixa’ and the Instituto de Salud Carlos III (ISCIII). It has also received funding from the Spanish Association Against Cancer (AECC) and the Bosch Aymerich Foundation.

ARI0002h: the first CAR-T developed entirely in Europe for multiple myeloma

Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow. It accounts for 10% of blood cancers and, although various treatments are available, many patients develop resistance, leading to relapses and an urgent need for new therapies to treat them. This is where CAR-T therapies can play a key role.

CAR-T ARI0002h has been developed entirely at IDIBAPS by Dr. Álvaro Urbano-Ispizua’s research group. It is the first European CART to demonstrate clinical efficacy in patients with multiple myeloma. Specifically, it is a CART that targets the BCMA antigen, which is found on the surface of myeloma tumour cells. Two previous studies led by the Clínic-IDIBAPS and published in the journals Lancet Oncology and Clinical Cancer Research have shown the efficacy of CAR-T ARI0002h in patients with multiple myeloma who have relapsed after at least two lines of treatment and are already exposed to the main drugs used in this disease.

The two studies validated the efficacy of the treatment in a total of 60 patients and the results showed that 95% of patients responded to treatment with a favourable toxicity profile.

Dr. Carlos Fernández de Larrea has led the clinical development of the CART ARI0002h, in which seven Spanish hospitals have participated: Hospital Clínic de Barcelona, Clínica Universidad de Navarra, Hospital Universitario de Salamanca, Hospital Virgen de la Arrixaca de Murcia, Hospital 12 de Octubre de Madrid, Hospital Virgen del Rocío in Seville and Hospital Clínico Universitario de Santiago. The preparation of the CARTs for administration to patients was carried out at the Hospital Clínic de Barcelona, by the Immunology Service team led by Dr. Manel Juan, and at the Clínica Universidad de Navarra.