Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Calibr, a division of Scripps Research
CLBR001 + SWI019 is novel switchable CAR-T cell combination therapy comprised of an autologous CAR (chimeric antigen receptor)-T product (CLBR001, the switchable CAR-T cell \[sCAR-T\]) and SWI019 (the "switch" biologic molecule). SWI019 acts as an adapter molecule that controls the activity of the CLBR001 CAR-T cell product.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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).
