NANJING and SHANGHAI, China, September 12, 2026 — IASO Bio today announced that FUMANBA-3 (Study No. CT103AC004; NCT ID: NCT06464991), a randomized, controlled Phase 3 registrational study of equecabtagene autoleucel (FUCASO), the world’s first fully human anti-BCMA CAR-T cell therapy product, in patients with multiple myeloma who have received one to two prior lines of therapy, has completed enrollment of all 240 patients. This marks a key milestone in the expansion of equecabtagene autoleucel into earlier lines of treatment following its approval by China’s National Medical Products Administration (NMPA) in June 2023 for adult patients with relapsed/refractory multiple myeloma (r/r MM) who have progressed after at least three prior lines of therapy.
FUMANBA-3 is a randomized, controlled, multicenter Phase 3 clinical trial designed to evaluate the efficacy and safety of equecabtagene autoleucel versus standard-of-care treatment in patients with lenalidomide-refractory multiple myeloma who have received one to two prior lines of therapy. The study enrolled 240 patients across 28 clinical centers in China. Since the first study site was initiated in May 2024, all patients have been enrolled in approximately 28 months.
Professor Lu-Gui Qiu, Leading Principal Investigator (Leading PI) of the study and Professor at the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, said: “Patients with second-and third-line multiple myeloma continue to face significant unmet medical needs, as existing standard therapies have limitations in achieving deep and durable responses. The efficacy and safety of equecabtagene autoleucel have been well established in patients who have received at least three prior lines of therapy. This study will determine whether equecabtagene autoleucel can deliver deeper and more durable responses in patients treated in earlier lines. We are pleased to see the study successfully complete enrollment. We would like to thank all participating investigators and patients for their trust and dedication, and look forward to the primary endpoint data providing high-quality evidence to inform clinical treatment decisions.”
Professor Zhen Cai, Leading PI of the study and Professor at the First Affiliated Hospital of Zhejiang University School of Medicine, said: “This is the first registrational Phase III CAR-T clinical study in China for patients with relapsed/refractory multiple myeloma who have received one to two prior lines of therapy and are lenalidomide-refractory. Completion of enrollment reflects the efficient collaboration among investigators, study teams and the sponsor. We will continue to ensure high-quality follow-up and data collection, and work closely with the independent review committee to complete efficacy assessments, with the goal of bringing this innovative therapy to more patients as soon as possible.”
Jinhua Zhang, Founder, Chairwoman and CEO of IASO Bio, said: “The enrollment of all 240 patients in the FUMANBA-3 study represents a key milestone in the advancement of the program and marks an important step in expanding equecabtagene autoleucel from later-line treatment into earlier lines of therapy. We would like to thank Professor Lu-Gui Qiu and Professor Zhen Cai, the study’s Leading PIs, for maintaining rigorous academic standards and providing oversight throughout the study, from protocol design through data verification. We also extend our sincere appreciation to the teams at all 28 participating clinical centers, including those led by Professor Jin Lu, Professor Wenming Chen, Professor Zhengzheng Fu and Professor Baijun Fang, as well as all participating patients, for their dedication and efforts in enabling the study to complete enrollment efficiently and with high quality. Going forward, IASO Bio will continue to work closely with all participating centers to advance the study and strive for the earliest possible readout of the primary endpoint data, with the aim of providing patients with multiple myeloma with earlier-line treatment options that offer greater accessibility and the potential for long-term disease control.
As part of this international multicenter Phase 3 clinical trial (MRCT), the Clinical Trial Notification (CTN) for the study in Japan received deemed clearance from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on March 24, 2026. IASO Bio looks forward to making this innovative cell therapy from China available to more patients in Japan and around the world.”
About the CT103AC004 Study
CT103AC004 (FUMANBA-3) is a randomized, controlled, multicenter Phase III registrational clinical study designed to evaluate the efficacy and safety of equecabtagene autoleucel versus standard-of-care treatment in patients with lenalidomide-refractory multiple myeloma who have received one to two prior lines of therapy. The study is being conducted at 28 clinical centers across China, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Leading PI: Professor Lu-Gui Qiu) and the First Affiliated Hospital of Zhejiang University School of Medicine (Leading PI: Professor Zhen Cai), and planned to enroll 240 patients in China.
About FUCASO (Equecabtagene Autoleucel)
FUCASO (equecabtagene autoleucel; overseas brand name: FUCASO) is a fully human anti-BCMA CAR-T cell therapy independently developed by IASO Bio. It was approved by China’s National Medical Products Administration (NMPA) on June 30, 2023, for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM) who have progressed after at least three prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory drug. FUCASO is the world’s first fully human CAR T-cell therapy to receive regulatory approval and enter commercial use. The product is currently being evaluated in a Phase 3 registrational study for second- to third-line multiple myeloma and has received multiple Investigational New Drug (IND) clearances in China and the United States for autoimmune disease indications. IASO Bio is also advancing the regulatory registration of FUCASO in multiple countries and regions.
