Elicera Therapeutics AB (publ) announced that it has received approval from the Swedish Medical Products Agency (MPA) on its Clinical Trial Application (CTA) to evaluate its CAR T-cell therapy, ELC-301, in treatment of patients with B-cell lymphoma (CARMA-study), conditional on certain further validations of its GMP-process. Elicera is acting co-sponsor together with Uppsala university. The clinical phase I/IIa-study, also called the CARMA-study, aims to evaluate the safety and efficacy of one dose of CD20 directed CAR T-cells, armed with bystander immune activating properties, using the iTANK-platform, in patients with relapsed and/or refractory B-cell malignancies, by studying tolerance, toxicity, biological effects, and anti-tumor responses.

The clinical trial will be conducted at the Academic hospital in Uppsala and at Karolinska University Hospital in two stages: a dose escalation stage (Phase I) to minimize the risk of serious side effects and to identify the appropriate testing dosage, followed by treatment in Phase IIa of the remaining six patients with the optimal dose identified in Phase I. Total of 12 patients are expected to be able to evaluate for safety and efficacy with the maximum tolerable dose. The dose escalation stage is expected to be completed and reported latest during first half of 2025 and stage 2 is expected to be completed and reports about 6-12 months later. The CARMA-study as a whole is expected to be completed and report during 2027 after all patients have been followed for at least two years.

The MPA grants the application for a clinical trial on the condition that Elicera carries out certain further validations of the GMP-process, which is estimated to be completed and finally approved during third quarter this year. Elicera's drug candidate, ELC-301, constitutes a fourth generation CAR T-cell therapy that targets the CD20 antigen which, like CD19, is expressed on all B-cell lymphoma cells. Elicera is armed with Elicera's iTANK--technology platform to elicit a dual mode-of-action and a broad attack on cancer by also activating the patients' own killer T-cells against the whole set of relevant antigen targets on tumor cells, not only against CD19 or CD20.

Development and preparations for the CARMA-study have been aided over the past year by grants from the European Innovation Council (EIC) Accelerator Programme and Vinnova. In combination with existing cash, the EU-funding is sufficient to fully fund the CARMA-study and the Vinnova grant will to be used to develop an automated CAR T-cell manufacturing process to be implemented according to Good Manufacturing Practice (GMP).