Innovation Frontline | Dual Indications for ALA/MN Enter Clinical Enrollment; Two New Studies Accepted by EHA 2026!

In terms of clinical progress, the autologous dual-targeting BCMA/CD19 CAR-T product FKC289 project has achieved several milestone advancements.On April 22, the national investigator meeting for the Phase I/II study of the project targeting relapsed/refractory primary light chain amyloidosis (R/R ALA) was successfully held in China. Investigators discussed the study protocol and project implementation details, reaching a multicenter collaborative consensus. Shortly after, on April 29, the national investigator meeting and kick-off meeting for FKC289 targeting relapsed/refractory membranous nephropathy (R/R MN) were subsequently held in China, marking its rapid advancement into the field of autoimmune diseases. Corresponding patient recruitment is currently underway with great urgency.

At the academic level, two latest research achievements have been accepted by the 31st Annual Meeting of the European Hematology Association (EHA 2026).Among them, one study is based on ctDNA-guided early secondary infusion of Axi-cel (Axicabtagene Ciloleucel Injection, CD19 CAR-T), exploring preemptive consolidation interventions for relapsed/refractory large B-cell lymphoma; the other focuses on the safety and efficacy of the autologous dual-targeted BCMA/CD19 CAR-T product FKC289 in relapsed/refractory primary light chain amyloidosis (R/R ALA).

EHA 2026 will be grandly held in Stockholm, Sweden, from June 11 to 14, 2026, local time. As one of the most influential academic conferences in the global hematology field, the European Hematology Association Annual Meeting is not only a platform for the release of cutting-edge achievements but also an important hub for promoting advances in diagnosis and treatment as well as international cooperation.

Two studies have been accepted, reflecting Fosun Kite's continuous exploration in cutting-edge mechanisms and clinical translation, and also indicating that the company's related achievements will receive more widespread attention on the international stage.

At the EHA 2026 conference, the exploratory study results on early secondary infusion of CD19 CAR-T guided by ctDNA as consolidation therapy, led by Professors Li Yuhua and Tu Sanfang from Zhujiang Hospital, Southern Medical University, made a significant appearance.

CD19 CAR-T Therapy Significantly Improves Treatment Outcomes in Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL). However, patients who fail to achieve deep remission early after the first infusion remain at high risk of relapse. Previous data indicate that a second CAR-T infusion after relapse or progression usually offers limited salvage efficacy. This study aims to evaluate the efficacy, safety, and cellular kinetics of an early second CD19 CAR-T cell infusion as consolidation therapy in R/R LBCL patients who showed initial response but failed to achieve deep remission after the first infusion.

Relapsed/Refractory Primary Light Chain Amyloidosis (R/R ALA) still presents significant unmet clinical needs. FKC289 is a dual-target autologous CAR-T product targeting both BCMA and CD19, which achieves deep depletion of pathogenic plasma cells and/or B cells by targeting the surface antigens BCMA and CD19. This inhibits the production of monoclonal immunoglobulin light chains and their misfolded amyloid proteins, alleviating tissue and organ damage. This study is an investigator-initiated first-in-human Phase I clinical trial (IIT, ChiCTR2500100410), aiming to evaluate the safety and preliminary efficacy of the BCMA/CD19 dual-target CAR-T product FKC289 in patients with R/R ALA.