NANJING, China, August 4, 2026
Leads Biolabs announced that its partner Oblenio Bio, a company jointly established with Aditum Bio, has successfully dosed the first patients in the Phase 1a first-in-human clinical trial of LBL-051, a CD19×BCMA×CD3 tri-specific T-cell engager being developed for refractory autoimmune diseases. The multicenter European study marks the first clinical evaluation of the investigational therapy, which is designed to induce complete depletion of B cells and plasma cells, enabling a durable immune system reset with the potential to achieve long-term drug-free remission. The milestone highlights the continued clinical advancement of Leads Biolabs’ proprietary LeadsBody platform, while reinforcing the company’s strategy of expanding innovative immune therapies beyond oncology into autoimmune disorders with significant unmet medical needs.
Phase 1a Study Evaluates Novel Immune Reset Strategy
The open-label, multicenter Phase 1a trial is enrolling patients with multiple refractory autoimmune diseases and will assess the safety, tolerability, clinical response, B-cell and plasma-cell depletion, together with biomarker changes following treatment with LBL-051. Administered through a subcutaneous dosing regimen, the study utilizes an innovative first-in-human dose-escalation design approved by Germany’s Paul Ehrlich Institute (PEI) to rapidly generate proof-of-concept data while maintaining patient safety. LBL-051 simultaneously targets CD19, BCMA, and CD3, enabling depletion of both pathogenic B cells and plasma cells, which are considered major drivers of autoimmune disease. The investigational therapy aims to provide a more durable therapeutic benefit than conventional single-target or bispecific approaches by delivering a comprehensive immune reset.
Preclinical Data Demonstrated Broad Immune Cell Depletion
According to previously presented EULAR 2026 preclinical findings, LBL-051 achieved complete depletion of peripheral and tissue B cells and plasma cells in non-human primate studies using a step-up dosing strategy. The therapy also promoted the recovery of immature, non-memory B cells, a biological pattern associated with long-lasting drug-free remission observed in autoimmune patients. Importantly, investigators reported minimal cytokine release, with no cytokine release syndrome (CRS) observed even at high exposure levels, while also demonstrating dose-dependent reductions in circulating immunoglobulins, confirming effective plasma-cell depletion. These findings support the therapy’s differentiated mechanism and its potential to deliver both strong efficacy and an improved safety profile in patients with difficult-to-treat autoimmune diseases.
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LeadsBody Platform Expands Beyond Oncology
Leads Biolabs stated that the advancement of LBL-051 into human clinical testing further validates the capabilities of its proprietary LeadsBody platform to generate globally competitive biologic therapies. Following the clinical progress of LBL-034 in hematologic malignancies, LBL-051 represents another important milestone as the platform expands into autoimmune disease indications. Under its collaboration with Oblenio Bio, Leads Biolabs continues to provide scientific and technical support while remaining eligible for development milestones, commercial milestone payments, and future royalties as the program advances globally. Company Founder, Chairman and CEO Dr. Xiaoqiang Kang noted that the successful initiation of the trial demonstrates the effectiveness of the company’s NewCo collaboration model, which combines China-based scientific innovation with international clinical development expertise to accelerate the delivery of next-generation therapies for patients worldwide
Source:Leads Biolabs press release
