💬In plain words
What the trial is, and whether it could suit you
This is an open-label investigator-initiated trial (IIT) to assess the safety, efficacy, and PK（pharmacokinetic）/PD（pharmacodynamics ） of UB-VV410 in adult subjects with clinically active treatment-refractory SLE. The study population will include subjects with active LN (as defined by evidence of active inflammation on renal biopsy, referred to as the LN cohort) and subjects with active SLE without LN (ie, non-LN SLE, referred to as the non-LN cohort). It is expected that the safety profile of UB-VV410 will be similar in subjects with active LN and subjects with active non-LN SLE; thus, dose finding (DF) will be conducted in the 2 subpopulation cohorts combined. Dose expansion (DE) may be conducted separately in the LN and non-LN cohorts to characterize the preliminary efficacy of UB-VV410, as well as its safety and PK/PD, in each subpopulation.
The objective of this study is to determ
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Age ≥ 18 and ≤65 at time of consent.
2. Provide voluntary written informed consent.
3. 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.
4. Current or history of elevated anti-dsDNA（anti-double-stranded DNA ） and/or elevated anti-Smith antibody.
5. 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
6. 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.
7. No serious concomitant diseases or active/uncontrolled infections.
8. 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.
9. 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.
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.
HealthTeky