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

Ki vehet részt

• Age ≥ 18 and ≤65 at time of consent
• Provide voluntary written informed consent
• Documented medical records indicated SLE diagnosis or diagnosis of SLE according to the 2019 EULAR（European Alliance of Associations for Rheumatology）/ACR（American College of Rheumatology） classification criteria for SLE for at least 6 months
• Current or history of elevated anti-dsDNA（anti-double-stranded DNA ） and/or elevated anti-Smith antibody
• Alanine aminotransferase (ALT) ≤ 2.5 × ULN（upper limit of normal）, aspartate aminotransferase (AST) ≤ 2.5 × ULN, AND total bilirubin < 1.5 × ULN (or AST, ALT, and alkaline phosphatase < 5 × ULN, and total bilirubin ≤ 3 × ULN for subjects with Gilbert's syndrome
• No ongoing coagulopathies requiring periodic replacement of clotting factors (eg, fresh frozen plasma, cryoprecipitate). Note: Subjects on a stable anticoagulant regimen > 6 months with activated partial thromboplastin time (APTT) ≤ 2.5 × ULN and international normalized ratio (INR) > 2 and < 3 are allowed on study
• No serious concomitant diseases or active/uncontrolled infections
• For LN-specific subjects: Active, biopsy-proven, proliferative LN with the classification of Class III or Class IV according to the 2018 revised ISN/RPS criteria. Note: Overlapping Class V is allowed
• For Non-LN SLE-specific subjects: SLEDAI-2K（Systemic Lupus Erythematosus Disease Activity Index 2000） score of ≥ 8 (including at least 4 points from non-laboratory assessments; ) and at least 2 BILAG（British Isles Lupus Assessment Group） B organ system scores, and/or at least 1 BILAG A organ system score, including, but not limited to, cardiac (peri- or myocarditis), respiratory (pleuritis or lung involvement), vascular, hematological and musculoskeletal

Ki nem vehet részt

• Diagnosis of drug-induced SLE rather than idiopathic SLE
• Receiving hemodialysis or peritoneal dialysis
• History of previous bone marrow transplantation, gene therapy, adoptive cell transfer, or any kind of CAR T-cell therapy
• 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
• 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
• Any acute, severe lupus-related flare that needs immediate treatment, such as acute pericarditis, catastrophic antiphospholipid syndrome, or acute CNS lupus (eg, psychosis, seizure)
• History of or active human immunodeficiency virus (HIV) infection
• 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
• Allergies to supportive medications required for CAR T-cell toxicity management (eg, tocilizumab)
• 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)
• 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
• Women who are pregnant or breastfeeding
• BILAG A for neuropsychiatric SLE