iCell Reports Promising Long-term Remission Data for BCMA CD19 cCAR in Lupus at EULAR 2024

iCell Gene Therapeutics has announced promising new long-term follow-up data from its BCMA CD19 compound chimeric antigen receptor (cCAR) T cell immunotherapy development program. This information was shared during an oral presentation at the European Alliance of Associations for Rheumatology (EULAR) 2024 Congress in Vienna, Austria. The data pertain to an investigator-initiated Phase 1 clinical trial of the BCMA CD19 cCAR in patients with systemic lupus erythematosus (SLE) suffering from lupus nephritis (LN).

The follow-up period for SLE patients has now extended to a mean of 20 months, while for LN patients, the mean follow-up is 16 months. The data further confirm that iCell’s BCMA CD19 cCAR therapy is well-tolerated and provides long-term, medication-free remission for SLE patients, including the 10 LN patients who received a dose of 3x106 cCAR cells/kg.

Key findings include the elimination of all elevated autoantibodies in all 12 patients, with each patient scoring 0 on the Physician Global Assessment. Remarkably, 11 out of 12 patients (92%) now meet the DORIS criteria for complete remission, an improvement from the previously reported 9 out of 12. Renal function has shown continued improvement in LN patients, with six patients diagnosed less than 10 years ago achieving a complete renal response. Two out of four patients diagnosed more than 10 years ago, or with chronic kidney disease, also showed renal function improvements. Follow-up renal biopsies in two patients revealed no active disease.

The cCAR treatment exhibited a favorable safety profile, with minimal infections reported and no severe cytokine release syndrome, CAR-T-cell-related encephalopathy syndrome, or immune effector cell-associated neurotoxicity syndrome. Humoral immunity has recovered in all LN patients.

Dr. Yupo Ma, Founder and Chief Scientific Officer of iCell, expressed excitement over the continued progress seen in LN patients treated with the BCMA CD19 compound CAR therapy. He highlighted the recovery of humoral immunity in all LN patients, with 11 patients achieving complete remission, elimination of elevated autoantibodies, and ongoing improvements in kidney function.

Greg Deener, Chief Executive Officer of iCell, described the BCMA CD19 compound CAR therapy as a differentiated approach with the most mature safety database among autoimmune cell therapy candidates. He emphasized the importance of the trial's findings in demonstrating the safe elimination of autoantibodies and delivering complete remission in the majority of patients, marking a potential breakthrough for those with lupus and other autoimmune diseases.

The study was conducted in two leading centers in China: Zhongshan People’s Hospital and Peking University Shenzhen Hospital. It initially involved two patients with SLE and localized lymphoma, later expanding to include 11 LN patients with biopsy-confirmed active disease. The treatment effectively depleted B cells and immunoglobulins within a short period post-cCAR therapy, with full recovery observed in a matter of months.

Overall, the cCAR therapy showed strong safety and efficacy in inducing medication-free remission and eliminating disease-causing autoantibodies in SLE and LN patients.

Systemic lupus erythematosus (SLE) is an autoimmune disease where the body's immune system attacks its own tissues, causing widespread organ damage. Lupus nephritis (LN) specifically affects the kidneys and is a serious complication of SLE. Standard treatments for LN come with significant side effects and do not target the underlying causes of the disease. iCell Gene Therapeutics aims to fill this treatment gap with its innovative CAR immunotherapy solutions.

iCell Gene Therapeutics is a clinical-stage biopharmaceutical company focused on developing chimeric antigen receptor (CAR) immunotherapies for treating unmet medical needs in autoimmune disorders and cancers. The company is actively conducting clinical trials in the U.S. and China, exploring various CAR technologies to improve patient outcomes.