Japan’s regulatory agency (PMDA) has cleared the Clinical Trial Notification for equecabtagene autoleucel (eque-cel; FUCASO). This BCMA-directed CAR T-cell therapy is indicated for adult patients with relapsed or refractory multiple myeloma (MM) who have received two or three prior lines of systemic therapy.
The clearance allows the expansion of an international, phase 3 trial (CT103AC004) into Japan. This multicenter study evaluates the efficacy and safety of the therapy against standard treatment in patients who have received 1–2 lines of prior therapy and are refractory to lenalidomide.
While the trial first launched in China in June 2024, the Japanese portion of the study is now set to begin, according to IASO Biotherapeutics, the manufacturer of the therapy.
Eque-cel is a fully human anti-B-cell maturation antigen chimeric antigen receptor T-cell therapy that uses a lentivirus as a gene vector to transfect autologous T cells.
In April 2025, the Macao regulatory body, ISAF, approved the therapy for the treatment of adult patients with relapsed or refractory multiple myeloma including at least one proteasome inhibitor and an immunomodulatory agent.
