A Study to Assess CLBR001+SWI019 in Subjects With Autoimmune Diseases

Launched by CALIBR, A DIVISION OF SCRIPPS RESEARCH · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment combining two medications, CLBR001 and SWI019, for patients with certain autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathy (IIM). The main goal is to see if this combination therapy is safe and effective, and to find out if a process called lymphodepletion (which helps prepare the body for treatment) is necessary for the treatment to work well. Participants will receive an infusion of CLBR001 cells and then regular doses of SWI019, with ongoing check-ups to monitor their health and how well the treatment is working.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of moderate to severe SLE with certain complications, SSc, or IIM. They also need to have tried at least two other treatments that did not work for them. However, there are some criteria that would exclude people from participating, such as having certain infections or recent treatments that might interfere with the study. The trial is not yet recruiting participants, but it aims to involve individuals who are willing to commit to long-term follow-up to see how they respond to the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Women or men age ≥18 of age at time of consent.
• • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of this study.
• • Adequate hematological, liver, pulmonary, and cardiac function
• • Willing to participate to participate in long term follow up study.
• • Confirmed diagnosis of moderate to severe systemic lupus erythematosus with lupus nephritis, systemic lupus erythematosus with extrarenal lupus, systemic sclerosis, and idiopathic inflammatory myositis.
• • Failed at least two immunosuppressive treatments
• Exclusion Criteria:
• • Inability to tolerate washout of prior therapy.
• • Not willing/understanding the requirements of the clinical study
• • Dependent on hemodialysis for a period of greater or equal to 3 months.
• • Known hypersensitivity to prednisone or to both tocilizumab siltuximab.
• • Have received plasmapheresis within 14 days prior to informed consent.
• • Active bacterial, viral and/or fungal infection.
• • Prior autologous/allogeneic stem cell transplant or solid organ transplant.
• • Prior lentiviral or retroviral based therapy including CAR-T cell therapy.
• • History or concurrent malignancy with active treatment in the past 5 years
• • HIV-1 and HIV-2 antibody positive subjects.
• • History of central nervous system diseases (such as seizure, psychosis, organic brain syndrome or cerebrovascular accident).