IASO Bio Receives Clearance from Japan's PMDA for CAR-T Therapy Clinical Trial

The company's BCMA-targeted CAR-T cell therapy Equecabtagene Autoleucel will be evaluated in relapsed/refractory multiple myeloma patients.

Mar. 24, 2026 at 10:15am

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IASO Biotechnology, a commercial-stage biopharmaceutical company, announced that its Clinical Trial Notification (CTN) for the BCMA-targeted CAR-T cell therapy Equecabtagene Autoleucel (Eque-cel) has been cleared by Japan's Pharmaceuticals and Medical Devices Agency (PMDA). The approved Phase III trial will evaluate the efficacy and safety of Eque-cel compared to standard therapy in patients with relapsed/refractory multiple myeloma who have received 1-2 prior lines of therapy and are refractory to lenalidomide.

Why it matters

Multiple myeloma is the second most common hematologic malignancy worldwide, and despite progress in current treatments, it remains largely incurable with multiple relapses and drug resistance. The clearance of this clinical trial for Eque-cel in Japan demonstrates the potential of this China-developed CAR-T therapy to address the unmet need for new treatment options for relapsed/refractory multiple myeloma patients.

The details

The approved trial (CT103AC004) is an international, multi-center, randomized, open-label, registrational Phase III study. IASO Bio will pursue an efficient review and registration pathway in Japan that combines small-sample clinical trials with support from global data packages, which is expected to reduce R&D costs and accelerate marketing approval.

  • The study was first initiated in China in June 2024 and is progressing smoothly.
  • The CTN for Eque-cel in late-line relapsed/refractory multiple myeloma was cleared by Japan's PMDA in October 2025.

The players

IASO Biotechnology

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.

Equecabtagene Autoleucel (Eque-cel)

IASO Bio's innovative fully human anti-BCMA CAR-T cell therapy that uses a lentivirus vector to transfect autologous T cells.

Japan's Pharmaceuticals and Medical Devices Agency (PMDA)

The regulatory agency responsible for approving clinical trials and marketing authorizations for pharmaceutical products in Japan.

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What they’re saying

“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.”

— Jinhua Zhang, Founder, Chairperson, and CEO of IASO Bio

What’s next

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The takeaway

This clearance for a clinical trial of IASO Bio's Eque-cel CAR-T therapy in Japan highlights the potential of China-developed cell therapies to address the unmet need for new treatment options for relapsed/refractory multiple myeloma patients globally.