Elicera Therapeutics receives approval to initiate clinical Phase I/II-study CARMA with CAR T-cell therapy ELC-301 in B-Cell lymphoma
Gothenburg, February 9, 2024 – Elicera Therapeutics AB (publ), a clinical stage cell and gene therapy company developing next generation cancer treatments based on its proprietary commercial technology platform iTANK, today announced that the company has received approval from the Swedish Medical Products Agency to start the clinical phase I/II study CARMA in patients with B-cell lymphoma that no longer respond to standard treatment or have relapsed.
CARMA is a single-arm, unblinded, multicenter study that aims to evaluate the safety profile and treatment effect after one dose of ELC-301. It is carried out on patients diagnosed with difficult-to-treat CD20-positive B-cell lymphoma, mantle cell lymphoma or indolent lymphoma, or who have relapsed in the disease. Among other things, the study will examine the treatment's anti-tumor effect, toxicity and tolerability.
The CARMA-study is carried out in two stages; a dose escalation phase (phase I) with a maximum of 12 patients, aimed at determining the optimal dose range, followed by a dose expansion phase (phase IIa) with a maximum of 6 patients receiving the maximum tolerated dose. A total of 12 patients are planned to be treated with the maximum tolerated dose. The study will be conducted at Uppsala University Hospital and Karolinska University Hospital in Huddinge. According to the company's preliminary timetable, the dose escalation study is expected to be completed and reported in the second half of 2025, and phase 2 is expected to be completed and reported approximately 6-12 months later. The full CARMA-study is expected to be completed and reported in 2027, after a follow-up period of at least two years.
"We are pleased that the Swedish Medical Products Agency has given the go-ahead for the start of our clinical study with ELC-301 in difficult-to-treat or recurrent B-cell lymphoma. The treatment has the potential to become a very important alternative for those patients whose disease no longer respond to standard therapy and thus lack effective treatment options. The study is also an important step in proving the enhancing function of our technology platform iTANK, which has the potential to activate the body's own immune system against cancer cells," says Jamal El-Mosleh, CEO of Elicera Therapeutics.
