Phase 1 Study of HBI0101 CAR-T Cell Therapy for Adults With Refractory B-Cell Autoimmune Rheumatic Diseases

What this Trial Is About

Researchers are evaluating HBI0101 BCMA-CART therapy in adults aged 18 to 80 with B-cell mediated autoimmune rheumatic diseases that have been resistant to standard treatments. This Phase 1, open-label study aims to assess the safety of this investigational CAR-T cell therapy and identify the highest dose that can be safely given to patients. The trial includes diseases such as systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myopathies, rheumatoid arthritis, multiple sclerosis, neuromyelitis optica spectrum disorder, myasthenia gravis, and antiphospholipid antibody syndrome. The study has two parts Part A focuses on establishing safety and determining the maximum tolerated dose through dose escalation, while Part B is an extension phase to further evaluate safety at the selected dose. Eligible participants will undergo a leukapheresis procedure to collect cells needed to manufacture the HBI0101 CART cells. Before receiving a single dose of either 450 million or 800 million BCMA CART cells, participants will undergo lymphodepletion. After receiving the CAR-T cell infusion, they will be hospitalized for several days and then attend routine follow-up visits for up to 48 months. Participants will be closely monitored through clinical exams, disease-specific assessments, and survival tracking for up to four years after infusion. Researchers will evaluate safety outcomes in the first 21 days and confirm safety over the longer term. Disease progression and response will be tracked using measures specific to each autoimmune condition. Participants will also be required to adhere to study visit schedules and protocols, including regular laboratory tests and clinical evaluations. This long-term follow-up aims to understand the safety profile and disease effects of HBI0101 CART therapy.

Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases