IASO Bio Announces Early Clinical Data from Investigator-Initiated Trial of Equecabtagene Autoleucel Injection in Patients with Refractory Lupus Nephritis at ACR Convergence 2026
All patients achieved rapid, deep and durable clinical remission, discontinuing glucocorticoids and immunosuppressants within two months post-infusion and maintaining drug-free remission, with a manageable safety profile.
SHANGHAI, NANJING, and PLEASANTON, CA—Nov. 9, 2026—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, announced that early clinical data of its independently developed, fully human BCMA-targeting CAR-T cell therapy product, equecabtagene autoleucel injection (brand name: FUCASO), for the treatment of refractory lupus nephritis (LN), were officially presented in a poster at the American College of Rheumatology (ACR) Convergence 2026, held in Orlando, USA.
The clinical data demonstrated that equecabtagene autoleucel exhibited a trend toward clinical remission in patients with refractory lupus nephritis. Among the three heavily pretreated subjects with severe disease who had completed 9 months of follow-up, all successfully discontinued glucocorticoids and immunosuppressants two months post-CAR-T infusion. No disease relapse was observed during the follow-up period, and the therapy demonstrated an overall manageable safety profile.
Disease Background and Study Design
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can affect multiple organ systems, and lupus nephritis (LN) is one of its most common and severe organ manifestations. Despite advances in available therapies, some patients respond inadequately to conventional immunosuppressive therapy or experience relapses, representing a significant unmet medical need. Equecabtagene autoleucel is the world's first fully human BCMA CAR-T cell therapy and has been approved in China for the treatment of relapsed/refractory multiple myeloma (R/R MM). Its development in autoimmune diseases now covers multiple indications, including immune-mediated necrotizing myopathy (IMNM), myasthenia gravis (MG), multiple sclerosis (MS), and systemic lupus erythematosus/lupus nephritis (SLE/LN).
The data disclosed are from an investigator-initiated trial (IIT) led by the Department of Rheumatology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology. The study enrolled adult patients with refractory/relapsed LN who met the 2019 ACR/EULAR classification criteria, had a SLEDAI-2K score of ≥8, and had biopsy-confirmed LN class III, IV, V, or III/IV+V. Following lymphodepletion preconditioning with cyclophosphamide and fludarabine, patients received a single infusion of equecabtagene autoleucel injection. As of May 8, 2026, the three patients who completed nine months of follow-up had all been heavily pretreated.
Efficacy Results: All Patients Achieved Renal Response and Maintained Drug-Free Remission
- All patients achieved SRI-4 response within one month of CAR-T infusion, and all subsequently achieved lupus low disease activity state (LLDAS); two of three patients achieved DORIS remission;
- All patients achieved partial renal response (PRR) or better, with two of them achieving complete renal response (CRR);
- All patients discontinued all glucocorticoids and immunosuppressants by Month 2 after CAR-T infusion and maintained drug-free remission throughout the follow-up period.
Safety Results: All CRS Events Were Grade 1, with No ICANS and No SAEs
- All cytokine release syndrome (CRS) events were Grade 1; no immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade was observed;
- Grade ≥3 adverse events were limited to neutropenia and decreased lymphocyte count, all of which were transient and fully resolved; no Grade ≥3 anemia or thrombocytopenia occurred (worst: Grade 2);
- No serious adverse events (SAEs) or deaths occurred.
Exploratory Observation: Concurrent Improvement in Comorbid Autoimmune Conditions
The study also observed potential benefit in comorbid autoimmune conditions. In Patient 002, who had concomitant psoriasis and Sjögren's syndrome, treatment resulted in near-complete clearance of psoriatic lesions, with marked improvement in xerostomia and xerophthalmia sustained through Month 9. These exploratory observations suggest that equecabtagene autoleucel holds great potential value in overlapping autoimmune conditions.
Poster Presentation Information
Poster Title: Preliminary Efficacy and Safety Results of Equecabtagene Autoleucel in Severe Refractory Lupus Nephritis, with a Case of Concomitant Psoriasis and Sjögren's Syndrome
Abstract Number: 2449938
Presentation Time: 10:30 AM–12:30 PM (U.S. Eastern Time), November 9, 2026
Chief Medical Officer and Senior Vice President of IASO Bio，Dr. Jie Chen，stated：“Autoimmune diseases are one of IASO Bio's key strategic therapeutic areas. The data presented at ACR Convergence 2026 represent an early clinical validation of equecabtagene autoleucel in lupus nephritis: we observed not only rapid, deep, and sustained clinical remission, but also pharmacodynamic evidence of profound B-cell depletion, disappearance of pathogenic autoantibodies, and restoration of complement levels — with clinical benefit and mechanism of action corroborating each other, further strengthening our confidence in this product. Enrollment in this study is ongoing. We will steadily expand development into more autoimmune indications, including necrotizing myopathy, myasthenia gravis, multiple sclerosis, and systemic lupus erythematosus, so that this innovative cell therapy can benefit more patients as soon as possible.”
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