IASO Bio Has Received Clearance from Japan's PMDA to Initiate Clinical Trial for CAR-T Therapy Equecabtagene Autoleucel in Second- or Third-Line Multiple Myeloma

SHANGHAI and NANJING, China and PLEASANTON, Calif., March 24, 2026 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of novel cell therapies and biologics for hematologic malignancies and autoimmune diseases, today announced that its Clinical Trial Notification (CTN) for its independently developed, fully human BCMA-targeted CAR-T cell therapy, Equecabtagene Autoleucel (Eque-cel), has been cleared by Japan's Pharmaceuticals and Medical Devices Agency (PMDA). The therapy is intended for the treatment of relapsed and/or refractory multiple myeloma (r/r MM) patients who have received 1-2 lines of prior therapies and are refractory to lenalidomide.

The approved trial (CT103AC004) is an international, multi-center, randomized, open-label, registrational Phase III study designed to evaluate the efficacy and safety of Eque-cel compared to standard therapy in patients with r/r MM who have received 1–2 lines of prior therapy and are refractory to lenalidomide. The study was first initiated in China in June 2024 and is progressing smoothly.

For its regulatory strategy in Japan, IASO Bio will pursue an efficient review and registration pathway that combines small-sample clinical trials with support from global data packages. This strategy is expected to significantly reduce the costs of standalone R&D in Japan and accelerate the marketing approval of the drug in the country.

Ms. Jinhua Zhang, Founder, Chairperson, and CEO of IASO Bio, commented: "Following the CTN clearance for Eque-cel in late-line r/r MM in Japan in October 2025, this subsequent clearance for second- 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."

About Multiple Myeloma (MM)

Multiple myeloma (MM) is the second most common hematologic malignancy worldwide. According to Globocan data, the global incidence rate of multiple myeloma in 2022 was 1.8 per 100,000 population, with a 5-year prevalence rate of 6.8 per 100,000. In Japan, the incidence rate of multiple myeloma in 2022 was 1.5 per 100,000 population, with a 5-year prevalence rate of 14.9 per 100,000.Despite progress in current anti-myeloma treatments, MM remains largely incurable with multiple relapses and tendency to develop refractoriness to several drug classes, presenting a major therapeutic challenge. Thus, there is an unmet need for new treatment options beyond these current anti-myeloma therapies for the treatment of relapsed or refractory MM, capable of achieving deep and durable responses.

About Equecabtagene Autoleucel (Eque-cel) 

Equecabtagene Autoleucel (Eque-cel) is an innovative fully human anti-BCMA CAR-T cell therapy which uses lentivirus vector to transfect autologous T cells. The CAR contains a fully human scFv, CD8a hinge and transmembrane, 4-1BB co-stimulatory and CD3ζactivation domains. Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, Eque-cel enables patients to achieve higher and deeper responses while maintaining a manageable safety profile.

About IASO Bio

Founded in 2017, IASO Bio is one of the few commercial-stage biopharmaceutical companies in the Advanced Therapy Medicinal Product (ATMP) sector bringing China's breakthrough innovations to the global market. We specialize in developing cell therapies and biologics for hematological malignancies and autoimmune diseases. Our industry-leading, fully integrated platforms leverage cutting-edge technologies that span the entire product lifecycle—from discovery and development to manufacturing and commercialization.

We have established a robust and synergistic pipeline, reflecting our commitment to making transformative cell therapies broadly accessible to patients worldwide. Our current portfolio includes ten products and product candidates, anchored by our core product, Equecabtagene Autoleucel (eque-cel). The CAR-T therapy Eque-cel has been approved in China for the treatment of relapsed or refractory multiple myeloma (r/r MM) in patients who have progressed after at least three prior lines of therapy. It is also being developed for use in earlier lines of r/r MM treatment and for autoimmune diseases, including myasthenia gravis (MG), multiple sclerosis (MS), and systemic lupus erythematosus (SLE)/lupus nephritis (LN). Beyond eque-cel, we are developing nine additional therapeutic candidates—including three autologous chimeric antigen receptor T-cell (CAR-T) therapies, five in vivo CAR-T cell therapies, and one antibody product candidate.

We collaborate with leading biotechnology and biopharmaceutical companies such as Innovent, Sana, Cabaletta, and Umoja, as well as top-tier academic institutions and hospitals, to strengthen our product development capabilities.

Leveraging our strong execution capability, an integrated and experienced management team in ATMPs, a robust pipeline, and advanced manufacturing and CMC capabilities, IASO Bio remains committed to making transformative cell therapies broadly accessible to patients worldwide.

SOURCE IASO Bio