Clinical Trial

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

Recruiting Phase 1
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Summary
A Phase 1 study of HBI0101 BCMA-CART in B-Cell Mediated Autoimmune Rheumatic Diseases. The goal of the study is evaluation of safety and identification of the maximum HBI0101 CART dose that may be administered safely to patients with B-cell mediated autoimmune disease.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-24.
Trial Details
NCT Number NCT07085676
Lead Sponsor Polina Stepensky
Conditions Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Multiple Sclerosis (MS) Primary Progressive, Multiple Sclerosis (MS) Secondary Progressive, Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG) +1 more
Enrollment 120 participants
Start Date 2024-09-01
Primary Completion 2026-11-01 (estimated)
Study Completion 2030-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-06