CAR-T therapy for B-cell lymphoma enters trials in Sweden

Blood samples in lab

Cell and gene therapy company Elicera Therapeutics has received approval from the Swedish Medical Products Agency to start the clinical Phase I/II study CARMA in patients with B-cell lymphoma who no longer respond to standard treatment or have relapsed.

CARMA is a single-arm, unblinded, multicentre 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-tumour effect, toxicity and tolerability.

ELC-301 is a CAR-T therapy that targets CD20, a tumour antigen target expressed on B-cells, for the treatment of B-cell lymphoma, mantle cell lymphoma or indolent lymphoma.

The study will be conducted at Uppsala University Hospital and Karolinska University Hospital in Huddinge. The dose escalation study is expected to be completed and reported in the second half of 2025, and Phase II 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.

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