Acepodia Completes Phase 1 Clinical Study Report for ACE1831 in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Clinical data expected to be presented at ACR Convergence 2026

Acepodia today announced the completion of the Phase 1 Clinical Study Report (CSR) for ACE1831 in patients with relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma (NHL). The primary objective of the study was to evaluate the safety, tolerability, recommended dose range, and preliminary clinical efficacy of ACE1831.

Based on the available data, ACE1831 demonstrated a safety and tolerability profile consistent with expectations for a Phase 1 study. No major safety concerns were identified that would limit future clinical development. Preliminary signs of clinical efficacy were also observed among patients evaluated, indicating biological activity in heavily pretreated relapsed/refractory hematologic malignancies.

In addition to evaluating safety and preliminary clinical efficacy, the study provided important experience in the development and clinical administration of CD20-targeted allogeneic γδ T-cell therapy, including cell manufacturing, logistics, patient monitoring, and treatment management. The Company believes these learnings and the resulting clinical data provide an important foundation for future development in B-cell–mediated autoimmune diseases.

The Company noted that the study represents an important milestone in the development of ACE1831 and further supports the clinical feasibility of its ACC platform technology. Given the critical role of B cells in multiple autoimmune diseases, Acepodia plans to continue advancing ACE1831 in autoimmune indications, including IgG4-related disease (IgG4-RD). The Company will also continue to evaluate potential partnership and licensing opportunities in hematologic malignancies.

“Completion of our Phase 1 study marks an important milestone for ACE1831, with a great deal of clinical experience and key knowledge gained by the team,” said Sonny Hsiao, Ph.D., Chairman and CEO of Acepodia. “The study has provided some valuable insights into safety, dosing feasibility, and clinical operation associated with our cell therapy, as well as preliminary observations for its clinical efficacy. These findings have not only validated our platform technology but also set the groundwork for subsequent development in the field of autoimmune diseases. With our future focus on its application in the IgG4-RD treatment, we will explore ACE1831 for its potential serving as an immune reset or in chronic disease control. ACE1831 has proved its clinical safety and preliminary efficacy in the study of hematologic malignancies. It shall further demonstrate its differential immunomodulatory capabilities and clinical values following our developmental success in autoimmune diseases, such as IgG4-RD in the future.

ACE1831 is a CD20-targeted allogeneic γδ T-cell therapy developed using Acepodia’s ACC platform technology. The Company is currently conducting a Phase 1b/2a clinical study of ACE1831 in IgG4-RD in the United States, Japan, and China. Acepodia believes the clinical experience and safety data generated from the NHL study provide a strong foundation for continued development in autoimmune diseases.

Additional safety, tolerability, and preliminary clinical efficacy data from the ACE1831 Phase 1 NHL study are expected to be presented at ACR Convergence 2026, to be held from November 6–11, 2026.

About Acepodia
Acepodia is transforming cancer and autoimmune disease treatment with first-in-class immune cell engagers that deliver enhanced and targeted potency through multiple conjugation platforms. Leveraging a family of bio-orthogonal click chemistry approaches originating from Nobel Prize laureate Carolyn Bertozzi’s lab, Acepodia’s platforms are designed to improve safety and offer broad applicability across hematologic and solid tumor cancers, as well as autoimmune diseases. Acepodia’s conjugation platforms are designed for modular integration across antibodies, immune cells, and payload architectures, enabling flexible application across diverse therapeutic modalities. By combining innovative science with a patient-centric vision, Acepodia aims to bring powerful, next-generation therapies to patients underserved by today’s treatments. For more information, please visit https://www.acepodia.com/.