Elicera Therapeutics 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.
“This is a major milestone for Elicera and for Swedish CAR T-cell research and development. This will be not only be the first time Elicera will enter clinical studies with a CAR T-cell therapy but also the first time that our CAR T-cell arming technology iTANK will be tested in a clinical setting. Moreover, as the only Swedish R&D-company developing CAR T-cell therapies in the country, Elicera has with this conditional approval taken a significant step towards meeting a high unmet medical need for patients who currently do not have any potentially curative treatment options,” says Jamal El-Mosleh, CEO of Elicera Therapeutics.
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. A 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 reported about 6-12 months later. The CARMA-study as a whole is expected to be completed and reported 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 Q3 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. ELC-301 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).
Photo of Jamal El-Mosleh