A new phase 2a clinical trial will test mRNA chimeric antigen receptor (CAR) T-cell therapy in patients with newly diagnosed, high-risk multiple myeloma.
Cartesian Therapeutics has launched a trial of Descartes-11, which expresses its CAR molecules transiently instead of permanently. Their proprietary cell therapy platform allows cells to express therapeutics with a defined half-life. This approach should reduce short-term and long-term risks inherent with conventional CAR T-cell therapies, according to a company press release.
The study (ClinicalTrials.gov Identifier: NCT04436029) will look at the safety and preliminary efficacy of the treatment in patients with myeloma who complete a pretransplant antimyeloma drug combination treatment (minimum of 2 drugs) but have residual disease after therapy. The primary outcome measure is rate of stringent complete response. The study aims to enroll 30 patients.
A phase 1 study of the therapy was conducted in patients with advanced disease. Results showed no evidence of typical CAR T-cell toxicities, such as cytokine release syndrome or neurotoxicity.
Commenting on the study in a press release, Kenneth Anderson, MD, Kraft Family Professor of Medicine at Harvard Medical School and Program Director of the Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics, said, “Patients newly diagnosed with high-risk multiple myeloma seldom achieve deep, durable responses after frontline therapy. Integrating a CAR T-cell therapy into our standard of care, without using lymphodepleting chemotherapy, would be a welcome addition to our toolkit for treating this currently incurable disease.”
Cartesian Therapeutics. Cartesian therapeutics initiates phase 2 clinical trial of first RNA-engineered cell therapy for frontline cancer [news release]. February 22, 2021.