UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis

Exclusion Criteria

• •1. Women who are pregnant or breastfeeding.
• •2. BILAG A for neuropsychiatric SLE.
• •3. Any acute, severe lupus-related flare that needs immediate treatment, such as acute pericarditis, catastrophic antiphospholipid syndrome, or acute CNS lupus (eg, psychosis, seizure).
• •4. Diagnosis of drug-induced SLE rather than idiopathic SLE.
• •5. Receiving hemodialysis or peritoneal dialysis.
• •6. History of previous bone marrow transplantation, gene therapy, adoptive cell transfer, or any kind of CAR T-cell therapy.
• •7. History of or active human immunodeficiency virus (HIV) infection.
• •8. Active hepatitis B (HepB) or hepatitis C (HepC). Note: Subjects with negative HepB virus DNA or a negative HepC virus RNA assay for viral load quantifications are permitted. Additionally, subjects who are positive for HepB surface antigen and/or anti-HepB core antibody with a negative HepB virus DNA are eligible.
• •9. Allergies to supportive medications required for CAR T-cell toxicity management (eg, tocilizumab).
• •10. Ongoing CNS diseases (eg, seizure disorder, tremor, history of cerebral vascular accident \[CVA\]/recurrent transient ischemic attack \[TIA\], cerebritis, substantial psychiatric disorder) that would preclude evaluation of immune effector cell-associated neurotoxicity syndrome (ICANS).
• •11. Serious and/or uncontrolled medical condition that, in the Investigator's judgment, would cause an unacceptable safety risk, interfere with study procedures or results, or compromise compliance with the protocol.
• •12. Major surgery within 12 weeks prior to administration of UB-VV410 or plans to undergo major surgery during the trial period and whom the Investigator considers to be at unacceptable risk.
• •13. Actively receiving treatment in other interventional clinical trials. Note: continued follow-up on previous trials is allowed for survivorship, but no further investigational agents or assessments will be allowed.