Elicera Therapeutics Receives Medical Products Agency Approval to Advance CARMA Study into Phase IIa in B-Cell Lymphoma
核心洞察
Sweden's Medical Products Agency approved a substantial modification to the CARMA trial authorization, allowing the ELC-301 CAR T-cell study to enter its Phase IIa dose-expansion part.
Six patients will now be recruited and treated at the recommended Phase II dose, which the independent DSMB selected after no dose-limiting toxicities appeared in Phase I.
In Phase I, all eleven evaluated patients achieved disease control and 91 percent had an objective tumor response, including six complete metabolic responses.
Elicera Therapeutics AB (搜索) said the Swedish Medical Products Agency (搜索) (Läkemedelsverket) has approved a substantial modification to the clinical trial authorization for the CARMA study, permitting the trial to proceed into its Phase IIa part. Patient recruitment can now begin, with six patients to be treated at the recommended Phase II dose.
CARMA is run with Uppsala University (搜索) as co-sponsor and comprises a completed Phase I dose-escalation part in 12 patients and a Phase IIa dose-expansion part in six patients. No dose-limiting toxicities were reported in Phase I, and the study's independent Data Safety and Monitoring Board reviewed the safety data and recommended the highest dose level as the Phase II dose. ELC-301 is a fourth-generation CAR T-cell therapy targeting the CD20 (搜索) antigen and armed with the company's iTANK platform, which incorporates a transgene encoding a neutrophil activating bacterial protein intended to drive a parallel bystander immune response via CD8+ killer T-cells.
Data reported on August 11 showed that among eleven patients treated and evaluated in Phase I, all achieved disease control and 91 percent (10/11) had an objective tumor response, including six patients (55%) with complete metabolic response as best response. Four of those six remained in ongoing complete response at their most recent assessment, two of them confirmed disease-free for at least twelve and eighteen months. The study is conducted at Uppsala University (搜索) Hospital and Karolinska University Hospital in Huddinge.