Uppsala, September 17, 2026 - Elicera Therapeutics AB (publ) announced today that the Swedish Medical Products Agency (Läkemedelsverket) has approved a substantial modification to the clinical trial authorization for the CARMA study, permitting the study to proceed into its Phase IIa part. Patient recruitment can now be started, with six patients to be treated at the recommended Phase II dose.
The CARMA study, conducted in collaboration with Uppsala University as the co-sponsor, consists of two parts: a dose-escalation study (Phase I) with 12 patients, which is now complete, and a dose-expansion study (Phase IIa) with 6 patients. The CAR T-cell therapy ELC-301 incorporates the iTANK platform technology, which, through its parallel immune activation, aims to provide a broader and more effective attack on cancer cells.
As previously communicated, no dose-limiting toxicities were reported in Phase I, and the study's independent Data Safety and Monitoring Board (DSMB), after reviewing the safety data, recommended the highest dose level as the Phase II dose. Following the Medical Products Agency's approval of a substantial modification to the clinical trial authorization, Phase IIa patients can now be recruited and treated at this recommended dose level.
The latest data reported from the CARMA study, press released on August 11, showed that among eleven patients treated and evaluated in the Phase I dose-escalation part, all had achieved disease control, and 91 percent (10/11) had obtained an objective tumor response, including six patients (55%) with complete metabolic response (CMR) (disease free status) as best response. Four of these six patients remained in ongoing complete response at their most recent assessment, with two of them confirmed disease-free for at least twelve and eighteen months, respectively.
"The Medical Products Agency's approval to move the CARMA study into Phase IIa is a significant milestone for Elicera. It means our clinical teams can now start treating patients at the dose we've identified as optimal, building directly on the depth and durability of response we've already seen during Phase I. I'm grateful to the patients, investigators and clinical teams in Uppsala and Stockholm who have made this possible. Our focus now is on enrolling patients as quickly as possible so we can bring this therapy closer to patients who need it," says Elicera's CEO, Johan Liwing