Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥18 and ≤65
- A clinical diagnosis of SLE, based on the 2019 European League Against Rheumatism
(EULAR)/American College of Rheumatology (ACR) classification criteria for adult SLE.
- Positive antinuclear antibody (ANA) titer or anti-dsDNA antibody at screening.
- For LN subjects only, active, biopsy-proven LN class III or IV, with or without the
presence of class V, according to 2018 Revised International Society of
Nephrology/Renal Pathology Society (ISN/RPS) criteria
- For non-renal SLE subjects only: Active, moderate to severe SLE
Exclusion Criteria:
- Contraindication to leukapheresis
- History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide
or any of their metabolites
- Active infection requiring medical intervention at screening
- Current symptoms of severe, progressive, or uncontrolled renal, hepatic,
hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or
cerebral disease, including severe and uncontrolled infections, such as sepsis and
opportunistic infections.
- Concomitant medical conditions that, in the opinion of the investigator, might place
the subject at unacceptable risk for participation in this study, interfere with the
assessment of the effects or safety of the investigational product or with the study
procedures
- For LN subjects only: The presence of kidney disease other than active lupus nephritis
- Previous CAR T cell therapy
- Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell
transplant.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 3/8/2024. Questions regarding updates should be directed to the study team contact.