Policy & Regulation
Elicera Therapeutics granted approval for ELC-301 CAR T-Cell therapy trial
9 February 2024 -

Clinical stage cell and gene therapy company Elicera Therapeutics AB (publ) (NGM:ELIC) announced on Friday that it has obtained approval from the Swedish Medical Products Agency to commence the Phase I/II CARMA study with ELC-301, a CAR T-cell therapy targeting CD20 for B-cell lymphoma patients who are unresponsive to standard treatments or have relapsed.

CARMA is an unblinded, multicenter study evaluating safety and treatment efficacy post-ELC-301 administration in CD20-positive B-cell lymphoma patients, including those with mantle cell lymphoma or indolent lymphoma. The study, divided into dose escalation (Phase I) and dose expansion (Phase IIa) stages, involves a maximum of 12 and 6 patients, respectively, with a total of 12 patients planned for treatment at the maximum tolerated dose.

Uppsala University Hospital and Karolinska University Hospital in Huddinge will conduct the study, with Phase I anticipated to conclude in the latter half of 2025 and Phase II to follow within 6-12 months. Full completion and reporting of the CARMA study are expected by 2027, after a minimum two-year follow-up period.

Elicera Therapeutics' ELC-301, developed using their iTANK platform, leverages CAR T-cell therapy armed with the NAP immune-activating protein to target tumour cells in addition to enhancing the body's immune response against cancer. The iTANK platform addresses challenges in CAR T-cell therapy for solid tumours by incorporating a transgene encoding NAP, which augments CAR T-cell function and induces a bystander immune response via CD8+ killer T-cells, facilitating a comprehensive attack on cancer cells.