SHANGHAI, NANJING, China and PLEASANTON, Calif., Oct. 16, 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 Cell published results from the study evaluating its independently developed fully human anti-BCMA CAR-T cell therapy, Equecabtagene Autoleucel (Eque-cel), for the treatment of progressive multiple sclerosis (PMS). This landmark study provides the world’s first clinical evidence confirming the safety and efficacy of a CAR-T therapy in PMS. It is also the first paper Cell has ever published on the successful application of BCMA-targeted CAR-T therapy for an autoimmune disease, representing a pivotal advancement in this field.
The study entitled ‘Anti-BCMA CAR-T Cells in Progressive Multiple Sclerosis’ has been published in Cell. Full text available at: www.cell.com/cell/fulltext/S0092-8674(25)01088-8. This study is based on an investigator-initiated trial (NCT04561557) led by Professor Wei Wang’s team from the Department of Neurology at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.
This study enrolled five patients with PMS，including 1 with primary progressive MS (PPMS) and 4 with secondary progressive MS (SPMS), with a mean age at disease onset of 38.2 years and a baseline mean Expanded Disability Status Scale (EDSS) score of 6.2. Following a single infusion of Eque-cel, the following outcomes were observed:
Significant efficacy: All five patients demonstrated significant improvements in EDSS scores, Nine-Hole Peg Test (9-HPT), and Timed 25-Foot Walk (T25FW) tests. Complete disappearance of cerebrospinal fluid oligoclonal bands (OCBs) and significant decrease in kappa free light chain (κFLC) levels were observed. Follow-up MRI scans revealed no new T1 gadolinium-enhancing lesions or new/enlarging T2 lesions.
Manageable safety profile: Only transient grade 1 cytokine release syndrome (CRS) occurred in 80% of patients, with no cases of ≥grade 2 CRS. No immune effector cell-associated neurotoxicity syndrome (ICANS) or other neurotoxic reactions were observed.
Professor Wei Wang from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, the principal investigator of this study, stated: “We are delighted to see our team’s research published in Cell, a significant milestone in the field of cell therapy. Our work has pioneered the application of anti-BCMA CAR-T therapy for multiple sclerosis and other refractory neuroimmune diseases, providing the world’s first clinical validation of both its safety and efficacy in patients with progressive MS. Notably, 83% of the refractory patients achieved long-term clinical remission without requiring ongoing medication. This study not only challenges the existing treatment paradigm but also reveals novel regulatory mechanisms within the central nervous system immune microenvironment, paving new directions for immunotherapy in chronic neuroinflammatory diseases.
Building on the remarkable efficacy of Eque-cel in clearing plasma cells and B cells, we are actively expanding the application of this therapy to a broader range of autoimmune diseases, including neuromyelitis optica spectrum disorders and myasthenia gravis, where we have already observed encouraging clinical outcomes. We are optimistic that this CAR-T therapy will offer a novel and powerful treatment option for more patients suffering from autoimmune diseases.”
Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Biotherapeutics, stated: “We are delighted that the research findings of Eque-cel for treating MS was published in Cell, one of the world’s most premier scientific journals, and congratulations to Professor Wei Wang and his team as the principal investigators for this accomplishment. This achievement further highlights IASO Bio’s pioneering innovation capabilities in the field of CAR-T cell therapy.
Autoimmune diseases are the key therapeutic focus for IASO Bio. Currently, Eque-cel has obtained multiple clinical trial approvals for autoimmune indications in both China and the U.S., including multiple sclerosis, myasthenia gravis, systemic lupus erythematosus and other autoimmune disorders. Moving forward, we remain committed to driving breakthroughs in autoimmune disease treatment through innovation, with the goal of delivering more advanced therapeutic options to patients worldwide.”
About Multiple Sclerosis
Multiple sclerosis (MS), a neuroinflammatory disease of the central nervous system (CNS) that causes demyelination and neuronal injury, is one of the most common causes of non-traumatic disability among young adults (aged 18–40 years)1. According to Frost & Sullivan Analysis reports, in 2023, about 3.07 million patients suffered from MS worldwide, of which approximately 400 thousand were in the United States and 50 thousand were in China. MS prevalence differs substantially between sexes, with a female to male ratio of 3:12.MS is characterized by focal lymphocytic CNS infiltration leading to myelin destruction and axonal damage, which result in neurologic syndromes and physical disability3. MS clinical manifestations depend on the location of lesions in the CNS. Symptoms may include sensory and visual disturbances; motor and coordination impairment; and spasticity, fatigue, pain, and cognitive deficits4. About 85%–90% of MS patients develop a relapsing-remitting form of the disease, which is characterized by periods of symptom exacerbation followed by remission. As the disease evolves, the recovery from symptoms is incomplete, and around 50% of patients eventually develop a form of the disease known as secondary progressive MS, which is characterized by the progressive, irreversible accumulation of neurologic disability5.
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1. Thompson AJ, Baranzini SE, Geurts J, Hemmer B, Ciccarelli O. Multiple sclerosis. Lancet 2018; 391: 1622–36. |
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2. GBD 2016 Multiple Sclerosis Collaborators. Global, regional, and national burden of multiple sclerosis 1990-2016: a systematic analysis for the Global Burden of Disease |
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Study 2016. Lancet Neurol 2019;18: 269–85. |
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3. Compston A, Coles A. 2008. Multiple sclerosis. Lancet 372(9648):1502–17. |
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4. BDendrou CA, Fugger L, Friese MA. 2015. Immunopathology of multiple sclerosis. Nat.Rev. Immunol.15(9):545–58. |
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5. Sospedra M, Martin R. 2016. Immunology of multiple sclerosis. Semin. Neurol. 36:115–27. |
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 demonstrates rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve higher and deeper responses.
