Elicera Therapeutics Approved for Phase IIa of CARMA Study
Elicera Therapeutics has received approval from the Swedish Medical Products Agency to advance the CARMA study into Phase IIa. This phase will treat six patients with B-cell lymphoma.
Uppsala, Sweden – Elicera Therapeutics AB (publ) announced it has received approval from the Swedish Medical Products Agency (Läkemedelsverket) for a substantial modification to its clinical trial authorization for the CARMA study. This approval permits the study to proceed into its Phase IIa part.
The CARMA study, conducted in collaboration with Uppsala University, consists of two parts. Phase I, a dose-escalation study involving 12 patients, has now been completed, marking a significant milestone for the drug development program.
The CARMA study is investigating Elicera Therapeutics' CARMA cell therapy, a modified CAR-T cell therapy, for patients with B-cell lymphoma. This type of cancer affects white blood cells and can be aggressive.
Patient recruitment for Phase IIa is now set to begin, with six patients slated to be treated at the recommended Phase II dose. The company has not provided a specific timeline for the completion of Phase IIa, but success in this stage is crucial for confirming the therapy's safety and efficacy.