Comparing 3 approaches for systemic lupus erythematosus (with and without nephritis)

Exclusion

• −Participants with active systemic bacterial, fungal, or viral infection requiring systemic treatment or a clinically significant active, opportunistic, chronic or recurrent infection.
• −Any active malignancy within 5 years prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →, except for adequately treated localized basal cell or squamous cell skin cancer, carcinoma in situ or low risk prostate cancer (Gleason score ≤ 6) under observation. Prior treatment of cancer with curative intent which in the opinion of the treating oncologist has less than a 10% chance of recurrence in the next 10 years can be allowed after discussion with the sponsorSponsorThe organisation responsible for the study overall.Read more →.
• −Clinically significant or unstable or uncontrolled acute or chronic disease (e.g., hypothyroidism and diabetes).
• −Symptomatic cardiac or vascular disease requiring medical intervention within 6 months prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, hemodynamically symptomatic pericardial effusion, or symptomatic electrocardiogram abnormality requiring medical intervention.
• −Child-Pugh Class B or C cirrhosis.
• −Symptomatic airway disease requiring medical intervention, pleural effusion ≥ Grade 2, or history of pulmonary embolism requiring anticoagulant therapy within 6 months of ALLO-329 dosing.
• −Participants known to be refractory to platelet or red blood cell transfusions or who will refuse indicated transfusion support to manage cell counts following treatment.
• −Any form of primary, inherited immunodeficiency.
• −Unwilling to participate in an extended safety monitoring period.
• −For participants with SLE: History or active disease involving CNS within the last 6 months or SLE that is drug-induced. For those with lupus nephritis, history of dialysis within 12 months prior to signing the informed consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more → or expected need for renal replacement therapy within the next 12 months after dosing, or National Institutes of Health (NIH) chronicity score of 3+ in any of the following domains: glomerular sclerosis, glomerular fibrous crescents, tubular atrophy, and/or interstitial fibrosis.
• −Participants with IIM: A myositis other than specified classification per exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →, non-reversible, unrelated or weakness not amenable to assessment, or dermatomyositis with presence of anti-TIF1 gamma antibody.
• −Participants with SSc: Pulmonary arterial hypertension requiring treatment, rapidly progressive or severe SSc gastrointestinal involvement, or prior scleroderma renal crisis.
• −Prior treatment with CD19 or CD70 targeted therapy or any prior engineered cell therapy (e.g., CAR T therapy), except prior treatment with ALLO-329 in this study.