An Open-label Phase 2a Study to Evaluate the Safety and Efficacy of AlloNK4, an Allogeneic Cord Blood-derived NK Cell Therapy, in Combination With Rituximab in Relapsing Forms of B-cell Dependent Rheumatologic Diseases

What this Trial Is About

Researchers are evaluating the safety and effectiveness of AlloNK, an allogeneic cord blood-derived natural killer NK cell therapy, combined with rituximab for people with relapsing forms of B-cell dependent rheumatologic diseases. These diseases include refractory rheumatoid arthritis, Sjgrens disease, idiopathic inflammatory myopathies, and systemic sclerosis. This Phase 2a open-label study aims to better understand how this combination therapy works in patients who have not responded well to previous treatments. Participants will receive AlloNK after a conditioning regimen in combination with rituximab. AlloNK is a non-genetically modified, off-the-shelf, cryopreserved NK cell therapy derived from cord blood. The treatment period includes dosing and follow-up to assess safety and response. The study does not involve placebo or blinding, and all participants receive the active combination therapy. During the study, participants will be closely monitored from enrollment through week 104 to assess safety. Disease-specific outcomes will be evaluated at week 52 using different clinical scores depending on the condition Disease Activity Score 28 DAS28 for rheumatoid arthritis, Clinical EULAR Sjgrens Syndrome Disease Activity Index ClinESSDAI for Sjgrens disease, Total Improvement Score TIS for idiopathic inflammatory myopathies, and Revised Composite Response Index in Systemic Sclerosis rCRISS for systemic sclerosis. Safety and effectiveness data will be collected through clinical assessments and laboratory tests over the course of the study.

AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases.