A new RNA-based cellular immunotherapy for haematological cancers approaches clinical trials

The immunotherapy strategies are based on getting the patient’s own defence cells, T-lymphocytes, to detect tumour cells and attack them. To do this, T cells are removed from the sick person, modified in the laboratory and re-injected again. These strategies to “redirect” T cells are having clinical impact in haematological cancers. In particular, therapies called chimeric antigen receptor (CARs) have transformed the prognosis of some types of leukaemias and lymphomas. But today, only a fraction of patients have significant long-term benefits.

The Joint Clinical Research Unit on Cancer Immunotherapy at the Hospital 12 de Octubre-Centro Nacional de Investigaciones Oncológicas (CNIO), led by Luis Álvarez-Vallina, is developing a pioneering cell therapy using immunotherapy and RNA technology. “Our cell therapy project is developing a new immunotherapy procedure to treat patients with haematological cancers. The therapy consists of isolating T cells from the patient and modifying them with an RNA sequence to produce molecular decoys (bispecific antibodies), which will allow the patient’s cells, once reintroduced, to identify and destroy tumour cells,” explains Álvarez-Vallina.

This is the STAR Project, funded by the State Research Agency (AEI) with 149,150 euros as part of the ‘Proof of Concept 2021’ call.

The new therapy has been tested in pre-clinical models and it is in the context of this Proof of Concept call that its viability is being studied in order to bring the product to market, beyond a scientific result.

This researcher and the other creators of the new immunotherapy, thanks to this grant, have set up a spin-off company to speed up the development of new cellular products with potential application in solid tumours, “to benefit patients as soon as possible”, adds Álvarez-Vallina.

The next steps will be to finalise pre-clinical validation, optimise cell production processes and initiate regulatory procedures with the Spanish Agency for Medicines and Health Products to be able to carry out a clinical trial. We expect this therapy to reach patients within the next two years.