Elicera Therapeutics includes the first patient in the Phase I/II clinical study CARMA targeting B-cell lymphoma
Gothenburg, November 5, 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, announced today that the first patient has been enrolled in the company's Phase I/II clinical study, CARMA. The study aims to evaluate the iTANK-armed CAR T-cell therapy, ELC-301, in patients with hard-to-treat B-cell lymphoma, mantle cell lymphoma, or indolent lymphoma who have not responded to standard treatment or have experienced a relapse of the disease.
The study will be conducted in two parts, with the initial phase involving dose escalation in 12 patients to determine the optimal dosing range for treatment with ELC-301. In the next phase, the maximum tolerable dose will be evaluated in an additional 6 patients, with a total of 12 patients expected to receive treatment at this dose level.
The study is being conducted at Uppsala University Hospital and Karolinska University Hospital in Huddinge. According to the company’s preliminary timeline, the dose escalation study, including 12 patients in total, is expected to be completed and reported in the second half of 2025. Data from the first dose group of three patients is expected to be reported in first quarter of 2025. Preliminary results from the second part of the study are anticipated approximately 6–12 months later. Following treatment, a follow-up period of at least two years will occur, meaning CARMA is expected to be completed and fully reported in 2028.
CARMA is a single-arm, open-label multicenter study aiming to evaluate the safety profile and treatment efficacy of a single dose of ELC-301. It targets patients diagnosed with relapsed or refractory CD20-positive B-cell lymphoma, mantle cell lymphoma, or indolent lymphoma. The study will examine, among other things, the treatment’s antitumor effect, toxicity, and tolerability.
“We are very pleased to finally begin our first clinical evaluation of ELC-301 and reach one of the most important milestones in our company history. It is an important step towards our goal of hopefully offering a new treatment for aggressive forms of B-cell cancer. The clinical development of ELC-301 will also provide us with important insights into our iTANK technology platform, which aims to generate a broad immune response against cancer cells,” says Jamal El-Mosleh, CEO of Elicera Therapeutics
