2025 IMS | IASO Bio Highlights Three-Year Follow-Up Data of CAR-T Cell Therapy Fucaso for Multiple Myeloma Treatment

SHANGHAI, NANJING, China and PLEASANTON, Calif., Sept. 18, 2025 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies, today announced that the 36-month long-term follow-up data from the FUMANBA-1 study of its independently developed fully human anti-BCMA CAR-T cell therapy Fucaso (Equecabtagene Autoleucel, Eque-cel), for the treatment of relapsed/refractory multiple myeloma (R/R MM), were presented at the 2025 International Myeloma Society (IMS) Annual Meeting. The results further demonstrate that Fucaso delivers deep and durable efficacy in patients with relapsed/refractory multiple myeloma (R/R MM), including those with high-risk features, along with a manageable long-term safety profile that significantly enhances overall survival quality^[1].

The results of this study were presented by Professor Lugui Qiu from Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences in an oral presentation at the IMS Annual Meeting (Abstract Number: 2142568). This presentation is based on findings from FUMANBA-1, a phase 1b/2 study evaluating the safety and efficacy of Fucaso, which was conducted at 14 sites in China. R/R MM patients who had received at least three prior lines of therapy and with progressive disease after the last line of therapy were enrolled. And patients with extramedullary disease (EMD) or prior exposure to anti-BCMA CAR-T therapy were included.

As of December 31, 2024, a total of 109 patients with R/R MM had received Fucaso, 12.8% had EMD and 11% had received prior BCMA CAR-T therapy. Following lymphodepletion with cyclophosphamide and fludarabine for three consecutive days, a single infusion of CAR-T cells (1×10⁶ cells/kg) was administered.

Deep and durable efficacy

Among 107 evaluable patients, the overall response rate (ORR) was 96.3%, including a complete or stringent complete response (CR/sCR) in 83.2%. In CAR-T–naïve patients, ORR and CR/sCR rates were 98.9% and 88.4%, respectively. Among 109 patients who received Eque-cel, the median progression-free survival (PFS) was 30.5 months, extending to 35.9 months in CAR-T–naïve patients. Median overall survival (OS) was not reached. Minimal residual disease (MRD) negativity was achieved in 95.3% (102/107) of evaluable patients, including all patients who achieved CR or sCR, the median duration of MRD negativity was 36.5 months.

Manageable long-term safety profile

• CRS occurred in 93.6% of patients, with only one case≥grade 3;
• ICANS was reported in two patients (grade 1–2);
• No late-onset neurotoxicity or secondary malignancies were observed.

Conclusion: At a median follow-up of 36.0 months, Fucaso therapy demonstrated deep, durable responses and sustained MRD negativity in heavily pretreated R/R MM patients, including those with high-risk features. The long-term safety profile remained manageable, with no new safety signals identified.

The principal investigators of this study, Professor Lugui Qiu, from Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, and Professor Chunrui Li, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, remarked: "We are delighted to present the three-year follow-up data from the FUMANBA-1 study of Eque-cel injection at this year's IMS Annual Meeting, and the results are highly encouraging. Due to its moderate antigen affinity, Eque-cel enables rapid binding and dissociation between CAR-T cells and tumor cells, contributing to a rapid onset of action and potent tumor clearance, thereby leading to deep responses in patients with relapsed or refractory multiple myeloma (R/R MM). Furthermore, as a human-derived CAR-T product, it exhibits low immunogenicity. While maintaining a low exhaustion phenotype, it achieves prolonged persistence, resulting in sustained antitumor activity and extended patient survival. It is particularly noteworthy that Eque-cel achieved a median progression-free survival (mPFS) of 35.9 months in CAR-T–naïve patients. These results indicate that the therapy can provide a longer treatment-free interval, significantly improve patients' quality of life^[1,3]."

Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Biotherapeutics, remarked: "We are greatly encouraged to see that the three-year follow-up data from the FUMANBA-1 study of Fucaso has once again confirmed its outstanding long-term efficacy and reliable safety profile. Notably, the complete response/stringent complete response rate among patients receiving BCMA CAR-T therapy for the first time has increased to 88.4%. Delivering sustained clinical benefits to patients with relapsed or refractory multiple myeloma remains our greatest motivation. The achievement of this important milestone is made possible through the collective efforts and unwavering dedication of both the investigator team and the IASO team. Building on the remarkable efficacy and safety profile of Fucaso, we are vigorously advancing the FUMANBA-3 clinical study for its second- and third-line treatments, while accelerating global registration and market access efforts to actively expand its presence in international markets. We look forward to making this high-quality CAR-T cell therapy accessible to a broader patient population worldwide."

About Equecabtagene Autoleucel (Fucaso) 

Equecabtagene Autoleucel (Fucaso) is an innovative fully human anti-BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully human scFv, CD8a hinge and transmembrane domain, and 4-1BB co-stimulatory molecule and CD3ζactivation domains. Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, Fucaso demonstrates rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve deep and durable remission, providing continuous protection and care for patients with multiple myeloma.

About Multiple Myeloma (MM)

Multiple myeloma (MM) is the second most common hematological malignancy globally. According to Globocan data, the global incidence of multiple myeloma in 2022 was 1.8 per 100,000 people, with a 5-year prevalence of 6.8 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 IASO Bio

Founded in 2017, IASO Bio is a leading biopharmaceutical company specializing in the discovery, development, manufacturing, and commercialization of cutting-edge cell therapies and biologics. Initially focused on treatments for hematological malignancies, the company has strategically expanded into autoimmune diseases.

IASO Bio boasts a robust drug development platform, encompassing early discovery to clinical trials, regulatory approval, and commercialization. The company is advancing a diverse pipeline of over 10 innovative products. Notably, Equecabtagene Autoleucel (Fucaso), the world' s first fully human CAR-T therapy developed by IASO Bio was approved by Chinese National Medical Products Administration (NMPA) in June 2023 for the treatment of relapsed and/or refractory multiple myeloma (R/R MM). The product has also been approved in Macau China; and its New Drug Application (NDA) in Hong Kong China, Singapore, and Saudi Arabia are currently under review; it has also received Orphan Drug Designation in South Korea; registration efforts in other countries are also steadily progressing. This product is also in Phase III clinical trials for second and third-line multiple myeloma (MM) and has received Investigational New Drug (IND) approvals in both China and US for autoimmune diseases. Meanwhile, the dual-target (CD19/CD22) product, CT120, for lymphoma was approved for Phase II clinical trials. Additionally, IASO118, another product targeting GPRC5D for the treatment of R/R MM, has received IND approval in China.

In addition to CAR-T therapies, IASO Bio is advancing IASO-782, a fully human anti-CD19 monoclonal antibody. This product has secured IND approvals in China and USA for several autoimmune diseases, with plans to explore additional autoimmune indications.

IASO Bio has established multiple global collaborations and licensing agreements with leading cell therapy companies, such as Sana Therapeutics, Cabaletta Bio, and Umoja Biopharma, underscoring its superior technology platform and commitment to next-generation cell therapies.

With a strong management team and execution capabilities, a robust pipeline, high-standard manufacturing and advanced clinical development capabilities, the company is well-positioned to drive innovation. It remains committed to accelerating the development of transformative therapies that address unmet medical needs for patients worldwide. For more information, please visit http://www.iasobio.com or www.linkedin.com/company/iasobiotherapeutics.

SOURCE IASO Bio