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Elicera Therapeutics to Start CAR T-Cell Therapy Trial in Sweden

NEW YORK – Elicera Therapeutics said on Friday that it will begin a Phase I/II clinical trial of its autologous CAR T-cell therapy ELC-301 in Sweden.

The Swedish Medical Products Agency has cleared the firm to begin the trial, dubbed CARMA, at the Uppsala University Hospital and the Karolinska University Hospital in Huddinge. In the trial, Elicera will evaluate the safety and preliminary efficacy of ELC-301 in patients with relapsed CD20-positive B-cell lymphoma, mantle cell lymphoma, or indolent lymphoma.

ELC-301 is designed to target CD20 on the surface of B cells. It also expresses the bacteria-derived neutrophil-activating bacterial protein, or NAP. According to Elicera, preclinical research shows that NAP can help activate the body's immune system to attack cancer. The firm developed ELC-301 using its technology platform ITANK, which incorporates a transgene into CAR T cells encoding NAP. According to the firm, NAP has been shown to enhance the CAR T cells, helping to address tumor antigen diversity and hostile tumor microenvironments.

In the initial Phase I dose-escalation part of the trial, Gothenburg, Sweden-based Elicera will enroll up to 12 patients. Then, after determining the maximum-tolerated dose, it will enroll an additional six patients to the study's Phase IIa portion.

Elicera expects to complete the dose-escalation portion of the study and report data during the second half of 2025. It expects to complete and report the Phase II portion of the trial roughly six to 12 months after that. The full study should wrap up in 2027, according to the firm.