The Spanish Agency of Medicines andMedical Products (AEMPS) has approved the CARxALL clinical trial led by thecompany OneChain Immunotherapeutics (OCI), member of CataloniaBioi &HealthTech. It will be the world’s first trial with CAR-Ttechnology for patients with a subtype of T-cell leukaemia.

The CARxALL trial will evaluate, forthe first time, the CAR-T CD1a (OC-1) therapy. This treatment specificallytargets a subtype of T-cell leukaemia, cortical T-cell acute lymphoblasticleukaemia (coT-ALL), which accounts for 30-40% of T-ALLs and has a poorprognosis in patients who do not respond to currently available treatments.

The trial will be conducted at HospitalClínic and Hospital Sant Joan de Déu in Barcelona, under the direction of Dr.Núria Martínez and Dr. Susana Rives, principal investigators for the study. It isexpected to include both paediatric and adult patients without any therapeuticalternatives. Although the patients will be treated inBarcelona, patients from Spain and across Europe may join the trial.

The group led by Dr. Menéndez, founder andCSO of OCI was the first in the world to develop and validate aCD1a-specific CAR-T for coT-ALL. The study, led by Dr. Diego Sánchez andpublished in the journals Blood andtheJournal forImmunoTherapy of Cancer, has been conducted with animal modelsusing cell lines derived from patients with coT-ALL. Preliminary results showthat these CAR-T cells persist in vivo in the long term and retain theiranti-leukaemia activity. 

OCI achieved this important milestoneafter being created in 2020 through a round of seed capital amountingto 3.05 million euros provided by Invivo Ventures, CDTI-Innvierte andthe Josep Carreras Foundation, and after receiving funding from the StateResearch Agency. This is a successful case of technology transfer andpublic-private collaboration involving recovery of public investment inresearch.

According to Dr. Menéndez, “Developingthese strategies and managing all the regulatory mechanisms associated withdeveloping a product is extremely complicated in the academic field. Therefore,OCI will enable us to carry out all the necessary steps to ensurethat our knowledge benefits patients”. 

LluísPareras and Albert Ferrer, founding partners of InvivoVentures, went on to say, “OneChain is developing several programmes in thefield CAR-T stemming from technology transfer. With its firstprogramme, OCI has demonstrated its ability to bring a product based onacademic research results to clinical trial in as little as two years. Inaddition, it has a new allogeneic platform, a haematological tumour programmeand a solid tumour programme in the pipeline”.