Gothenburg, August 11, 2026 - Elicera Therapeutics AB (publ), a clinical stage cell and gene therapy company developing next generation cancer treatments based on oncolytic viruses and CAR T-cell therapies, armed with immune-activating properties via the company's commercially available iTANK platform, today announces that the twelfth and final patient in the Phase I part of the CARMA study has been treated, and simultaneously provides a data update. Among the eleven patients evaluated to date, all have achieved disease control (no disease progression) one month after treatment, and 91 percent (10/11) have obtained an objective tumor response, including six patients (55 percent) with complete metabolic response (disease-free status) - of whom four still remain disease-free, one for at least 18 months and one for at least 12 months.
The CARMA study is a clinical Phase I/IIa trial evaluating the safety, optimal dosing, and preliminary efficacy of ELC-301 in patients with relapsed or refractory B-cell lymphoma that have undergone at least two previous lines of standard treatment with no remaining curative treatment options. The study includes a dose-escalation phase (Phase I) with twelve patients across three cohorts to identify the maximum tolerated dose, followed by further evaluation of six patients in an expansion phase (Phase IIa).
Key highlights from the data:
As soon as the twelfth and final patient in the Phase I part of the CARMA study has undergone their follow-up evaluation, the study's independent Data Safety and Monitoring Board (DSMB) will assess the third and final cohort. The DSMB's assessment will then determine the recommended Phase II dose (RP2D) to be used for continued enrollment in the dose-expansion part of the study (Phase IIa), where an additional six patients will be treated at the maximum tolerated dose.
"The eleven patients evaluated so far in the CARMA study continue to show strong data, with disease control in all patients and tumor responses in 91 percent. Three of them had previously received CAR T treatment and relapsed and are therefore defined as particularly difficult to treat. Among the three most recently included patients, one had stopped responding to their previous CAR T treatment - yet still achieved a tumor response with ELC-301. Particularly encouraging is that four of the six patients who achieved complete metabolic response remain disease-free, with one patient now disease-free for at least 18 months and another for at least 12 months. This is an early but important indication that the responses may be durable rather than temporary, which is critical for patients in this difficult-to-treat group and strengthens our confidence in the potential of ELC-301 and the iTANK platform. We now look forward to completing the evaluation of the final patient in the Phase I study, after which the DSMB will assess the last cohort ahead of the decision on continued enrollment in the dose-expansion part," says Jamal El-Mosleh, CEO of Elicera Therapeutics.