BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease
brief summary
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory autoimmune disease, even after relapse following other treatments. This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against refractory autoimmune disease using a BAFF CAR-T cell manufacturing process with or without lymphodepletion regimen.
detailed description
LMY-922 is an allogeneic CAR-T cell therapy consisting of allogeneic cluster of differentiation 4 (CD4) positive and cluster of differentiation 8 (CD8) positive human T cells that are genetically engineered using the non-viral transposon system to express the BAFF-ligand CAR-T that target BAFF receptor family members to eliminate pathological B cells. BAFF receptor family includes B-cell activating factor receptor (BR3), B-cell maturation antigen (BCMA) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI). These receptors are present on the B cells of patients with refractory autoimmune disease. The goal of LMY-922-001 phase 1 study is to find the recommended phase 2 dose of LMY-922 for treatment of patients with refractory autoimmune disease.
official title
A Phase 1 Study of Allogeneic (γ/δ) BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease