This outcome provides clinical validation of the company’s pioneering “ultra-low-dose + lymphodepletion-free” strategy across both hematologic malignancies and autoimmune diseases. The approach challenges the long-standing paradigm that effective CAR-T therapy requires high cell doses combined with lymphodepleting chemotherapy.

By eliminating pre-conditioning and using substantially lower cell doses, this strategy has the potential not only to reduce treatment-related toxicity, shorten recovery time, and preserve endogenous immunity, but also to significantly lower overall costs by eliminating the need for chemotherapy, reducing hospitalization requirements, and minimizing the burden of managing preconditioning-related complications. Importantly, it may expand access to frail or heavily pretreated patients who are often ineligible for preconditioning regimens.

Platform Foundation: Overcoming T-Cell Exhaustion Through Metabolic Reprogramming
META 10-19 is developed on Leman Biotech's proprietary META 10 platform, a first-in-class IL-10-mediated metabolic reprogramming technology designed to overcome T-cell exhaustion—a key barrier to durable responses in adoptive cell therapy.

Powered by META 10’s unique metabolic enhancement design, META 10-19 demonstrates markedly superior in vivo expansion capacity compared with conventional CAR-T therapies, achieving potent expansion at just 0.1% to 1% of the standard dose. This ultra-low-dose paradigm could simplify CAR-T manufacturing, improve production efficiency, and further reduce treatment costs —an important step toward broader patient access.

Clinical Evidence Across Oncology and Autoimmunity

Systemic Lupus Erythematosus (SLE)
Building on this capability, the clinical team adopted a lymphodepletion-free strategy for the treatment of moderate-to-severe SLE. Multiple patients achieved DORIS-defined complete remission off all medications following a single ultra-low-dose META 10-19 infusion (0.1% of standard CAR-T dose), without lymphodepleting chemotherapy or interruption of baseline therapy.

These results suggest meaningful improvements in efficacy, safety, and accessibility, with the potential to enable outpatient treatment and reduce overall healthcare costs.

Hematologic Malignancies
Encouraged by the SLE results, investigators expanded the lymphodepletion-free approach to relapsed/refractory hematologic malignancies. The first MCL patient treated under this regimen achieved complete remission, with the following clinical timeline:

• Day 17: Cerebrospinal fluid (CSF) minimal residual disease (MRD) turned negative
• Day 32: Patient discharged from hospital
• Day 39: Deauville score of 1 with no enhancing lesions on MRI/PET-CT, confirming complete remission

The patient, a female with multiply relapsed MCL involving bone as well as the central and peripheral nervous systems, had failed multiple prior lines of therapy (R-CHOP, R-DHAP combined with targeted agents). Due to low baseline lymphocyte counts, she was ineligible for standard lymphodepletion. She received META 10-19 in January 2026 without preconditioning.

Strategic Significance
The achievement of lymphodepletion-free complete remission in high-risk MCL patient, together with the encouraging SLE results, highlights the potential of metabolic reprogramming to reshape both the risk-benefit and cost-benefit profile of cell therapy.

By reducing the required cell dose by 10- to 1,000-fold and eliminating the need for conditioning chemotherapy and associated hospitalization, this approach may significantly lower the overall cost of care while improving both efficacy and safety.

The combination of "ultra-low-dose + lymphodepletion-free" treatment can expand patient eligibility, reduce treatment complexity, and support broader adoption of CAR-T therapy across both oncology and autoimmune indications.

Development Outlook
Leman Biotech will continue to advance multi-center clinical studies, further evaluate the lymphodepletion-free paradigm, and optimize clinical protocols. The company remains committed to accelerating the clinical translation of its META 10 platform to deliver safer, more effective, and more accessible therapies for patients worldwide.

About META 10-19
META 10-19 is a novel CD19-targeted CAR-T therapy developed by Leman Biotech based on META 10, its breakthrough metabolic reprogramming technology originating from École Polytechnique Fédérale de Lausanne (EPFL), Switzerland. META 10 overcomes T-cell exhaustion through IL-10-mediated metabolic enhancement, enabling potent anti-tumor immunity at ultra-low doses and potentially eliminating the need for toxic lymphodepleting chemotherapy in select indications.