Shanghai, China, June 9, 2026 – JW Therapeutics (HKEx: 2126) today announced the presentation of two new studies on relma-cel (relmacabtagene autoleucel) at the 2026 European Congress of Rheumatology (EULAR 2026): a Phase 1 clinical study in relapsed/refractory systemic lupus erythematosus (SLE) and a longitudinal multi-omic analysis study in systemic sclerosis (SSc). These data demonstrate JW Therapeutics' active progress in the field of CAR-T therapy for autoimmune diseases.
Abstract N°: 122
Complete Dose Escalation of Relma-cel, a CD19-Directed Autologous CAR-T Cell Therapy, in Relapsed/Refractory Systemic Lupus Erythematosus: A Phase 1/2 Clinical Trial
Junyan Qian, Chunyan Zhang, Yuzi Tian, Cuiwei Xie, Peng Xia, Zhen Xia, Hongjun Zhao, Liangjing Lu, Xiaofeng Zeng
Systemic lupus erythematosus (SLE) is a complex autoimmune disease. Lupus nephritis (LN) is a common and serious complication. Current treatment options have limitations, creating an urgent need for more effective therapies.
Relma-cel is the first commercialized CAR-T product approved for SLE clinical studies in China. Early clinical findings of relma-cel in SLE/LN have been incorporated into the Chinese Guidelines for the Diagnosis, Treatment and Management of Lupus Nephritis (2025 Edition).
The Phase 1 results presented at EULAR 2026 further validate the therapeutic potential of CD19 CAR-T therapy in autoimmune diseases and provide an important basis for advancing relma-cel into Phase 2 clinical studies.
Results: As of August 13, 2025, 12 patients were enrolled and assigned to receive relma-cel at doses of 50 (n=3), 75 (n=3), or 100 × 10⁶ cells (n=6). All participants were female, with a median age of 27 years and median disease duration of 9.5 years. All patients had renal involvement (BILAG A/B) and had received at least two classes of standard SLE therapies. The maximum tolerated dose was not reached. Grade 1 CRS occurred in 11 patients (92%), resolving after a median of 5.6 days with tocilizumab or glucocorticoids. One patient (8%) in the 75 × 106 group experienced grade 2 ICANS, which resolved within 4 days with sedative and antiepileptic therapy. No grade ≥ 2 CRS, grade 1 ICANS, or dose-limiting toxicities were reported. All 12 patients completed ≥ 6 months of follow-up. All (100%) achieved SRI-4 response, 50% (6/12) attained LLDAS, and 25% (3/12) met the DORIS remission criteria.
Conclusions: Phase 1 segment of this ongoing trial demonstrates a favorable safety profile and promising efficacy of relma-cel in SLE, supporting further development in the phase 2 portion of this study in China.
Abstract N°: 1517
LONGITUDINAL MULTI-OMIC ANALYSIS OF CD19 CAR-T CELL THERAPY IN SYSTEMIC SCLEROSIS DEMONSTRATES COORDINATED IMMUNE AND STROMAL MODULATION
H.Yin, Z. Zhao, C. Jia, W. LIN, F. Wu, D. Zhe, X. Liu, L. Lu
Systemic sclerosis (SSc) is a severe autoimmune disease characterized by immune dysregulation, microvascular injury, and progressive tissue fibrosis, which can affect multiple vital organs and lead to irreversible damage. Patients with progressive diffuse cutaneous SSc, in particular, have limited treatment options and a significant unmet clinical need.
In recent years, CD19 CAR-T cell therapy has shown promising potential in SSc and other autoimmune diseases. In a phase 1 open-label trial (NCT06414135), we assessed relmacabtagene autoleucel(relma-cel) in progressive diffuse cutaneous SSc. Relma-cel demonstrated a favorable safety profile across six patients. All patients achieved deep B-cell depletion, significant improvement in skin thickness scores, stabilization or improvement of interstitial lung disease, and marked reduction in autoantibody levels, indicating preliminary efficacy.
At EULAR 2026, Dr. Yin Hanlin, on behalf of the team of Professor Liangjing Lu from the Department of Rheumatology and Immunology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, was invited to present the longitudinal multi‑omic analysis results of relma-cel in systemic sclerosis (SSc) as an oral presentation.
Results: Single-cell RNA analysis of peripheral blood mononuclear cells identified 7,486 B cells, subclustered into naïve B cells, memory B cells (switched and non-switched), age-associated B cells, and antibody-secreting cells. Naïve B cell proportion increased by day 90 (D90), while plasma cell proportion was markedly reduced. Memory B cells (switched) decreased at D90 and partially recovered by D180, reflecting post-treatment immune remodeling. Single sample gene set enrichment analysis (ssGSEA) revealed downregulation of B-cell activation, differentiation, and BCR signaling pathways by D180. IGHG and IGHA isotypes were largely eliminated post-treatment and did not return to baseline by D180. Clonal expansion and diversity among B-cell subtypes were reduced. Naïve T-cell proportions decreased at D90 and recovered by D180, whereas effector memory T cells showed the opposite trend. T-cell subtypes showed reduced signatures of type I interferon post-treatment. T cell activation, differentiation and TCR signaling pathways were also downregulated by D180. Clone diversity of T cell decreased at D90. For skin single-cell RNA analysis, we identified a CTHRC1-high dermal fibroblast subcluster, which carried the strongest myofibroblast signature and resembled pathogenic fibroblasts found in various fibrotic diseases. Over time, it exhibited a broad downregulation of key pro-fibrotic pathways-encompassing cytokine signaling, matrix production, and differentiation pathways-which aligned with clinical improvement. Besides skin endothelial cells exhibited reduced endothelial-mesenchymal transition signatures. Spatial transcriptomics identified a fibrosis-associated gene module-including collagens(COL1A1, COL1A2, COL3A1, COL6A1-3), ECM components(DCN, LUM, FN1, SPARC, BGN, CCN2), and activated fibroblast markers(SFRP2, COMP, POSTN)-whose expression was significantly reduced at D90 and further decreased at D180. Longitudinal proteomics analysis showed decreased levels of molecules linked to skin fibrosis (e.g. CD93, GDF15), ILD (IL18, MMP19), and vascular injury and inflammation (e.g. CCN1, IFI16).
Conclusions: Our multi-omic analysis demonstrates that CD19 CAR-T cell therapy induces profound B-cell depletion and remodeling of the immune landscape in patients with progressive SSc. The observed reduction in pathogenic B-cell subsets, autoantibody production, and fibrotic gene module expression correlates with clinical improvements in skin and lung involvement. These findings suggest that CAR-T therapy may mitigate disease progression through coordinated modulation of adaptive immunity and fibroblast activation.
JW Therapeutics remains committed to “Innovating cures, shaping what's next.” The Company will continue to advance clinical research and scientific exploration of relma-cel in SLE, SSc, and other autoimmune diseases, generating further clinical evidence to deepen the application of cellular immunotherapy and bring more treatment options to patients.
About JW Therapeutics
JW Therapeutics (HKEX: 2126) is a biotechnology company focused on innovation in cell immunotherapy. Founded in 2016 through a collaboration between WuXi AppTec and Juno Therapeutics, the company combines global expertise in cell therapy research and development with local commercialization capabilities in China. It is dedicated to advancing the discovery, development, manufacturing, and commercialization of cell immunotherapy products, with the goal of improving access to innovative treatments in China and worldwide.We continue to build an integrated platform spanning scientific discovery, process development, manufacturing, quality management, and clinical application. Focusing on hematologic malignancies, solid tumors, and autoimmune diseases, we are advancing a differentiated pipeline of cell immunotherapy candidates while establishing comprehensive capabilities in commercial-scale manufacturing and end-to-end quality management.Guided by our mission of “Innovating cures, shaping what's next,” JW Therapeutics is committed to bringing more high-quality cell immunotherapy treatment options to patients and delivering new hope to patients in China and around the world.
About Relmacabtagene Autoleucel Injection
Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: Carteyva®) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, Carteyva® has been approved by NMPA for three indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), and the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) after two or more lines of systemic therapy including bruton tyrosine kinase inhibitors (BTKi), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations.
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