IASO Biotechnology has received Clinical Trial Notification (CTN) clearance from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to begin a Phase III study of equecabtagene autoleucel cell therapy for relapsed or refractory multiple myeloma (r/r MM).
Equecabtagene autoleucel is a B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor T-cell (CAR-T) therapy.
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The multi-centre, international, open-label, registrational, randomised trial will enrol Japanese patients with r/r MM who have undergone one or two prior therapies and are refractory to lenalidomide.
It aims to compare the safety and efficacy of equecabtagene autoleucel with standard therapies in patients with r/r MM.
The trial initially began in China in June 2024 and is reported to be progressing as planned.
For regulatory strategy in Japan, IASO Biotechnology intends to pursue a review and registration pathway that leverages smaller-sample domestic trials, along with global data packages.
This approach is designed to cut the costs associated with standalone research and development efforts in the country and expedite the potential marketing approval process for equecabtagene autoleucel.
The therapy uses lentivirus vectors to transfect autologous T cells. It was developed through molecular structure screening and functional evaluations to achieve deep responses with manageable safety.
IASO Biotechnology founder, chairperson and CEO Jinhua Zhang said: “Following the CTN clearance for Eque-cel in late-line r/r MM in Japan in October 2025, this subsequent clearance for second-line or third-line indications further demonstrates the high recognition by Japan’s PMDA of the product’s clinical value and the strength of China’s clinical data.
“This also lays a solid foundation for us to efficiently advance global development of our products through the MRCT [multi-regional clinical trial] pathway. We will accelerate the progress of relevant clinical trials and look forward to benefiting more patients in Japan and around the world with this advanced China-developed CAR-T therapy as soon as possible.”
Cell & Gene therapy coverage on Clinical Trials Arena is supported by Cytiva.
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