A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Systemic … (NCT06429800) | Clinical Trial Compass
WithdrawnPhase 1
A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Systemic Lupus Erythematosus
Stopped: Financial
United States0Started 2025-04-16
Plain-language summary
The purpose of the study is to evaluate the safety and preliminary efficacy of ATA3219 for treatment of participants with lupus nephritis (LN) following lymphodepletion (LD) and in participants with extrarenal systemic lupus erythematosus (SLE) without LD.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Diagnosed with SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology classification for SLE OR the Systemic Lupus International Collaborating Clinics Classification criteria \[Petri 2012\].
✓. Meets one or more of the following immunologic criteria during screening:
✓. Anti double stranded DNA above laboratory reference range, except enzyme linked immunosorbent assay (2 × above laboratory reference range), OR
✓. Presence of one or more of following autoantibodies: anti-Smith, anti-ribonucleoprotein, or anti-phospholipid, OR
✓. Low complement as demonstrated by low complement component 3, low complement component 4, or low complement CH50.
✓. Adequate lung, liver, kidney, and cardiac function.
✓. History of International Society of Nephrology (ISN)/Renal Pathology Society (RPS) Class III or IV with or without Class V glomerulonephritis on renal biopsy either within 6 months prior to screening or as performed during screening. Biopsy should demonstrate evidence of active nephritis.
✓. Proteinuria level between ≥ 1.0 to 6.0 g/g via urine protein creatinine ratio during screening.
Exclusion criteria
✕. Has a concurrent systemic autoimmune disease that may confound study assessments other than SLE, LN, or cutaneous lupus erythematosus.
✕. Has any unstable or progressive manifestation of SLE that is likely to warrant an intensification of lupus-directed therapy
What they're measuring
1
Number of Participants With treatment-emergent adverse events, including adverse events of special interest
Timeframe: From administration of pretreatments (LD or methylprednisolone) through 90 days after administration of study drug
2
Number of Participants With Dose-limiting Toxicities
Timeframe: Day 1 through Day 28 of first dose of study drug
3
Maximum Tolerated dose
Timeframe: Day 1 through Day 28 of first dose of study drug
4
Recommended Phase 2 dose of ATA3219
Timeframe: Day 1 through Day 28 of first dose of study drug
✕. Has a history of catastrophic antiphospholipid syndrome, or any history of prior thrombosis due to antiphospholipid syndrome resulting in hospitalization due to myocardial infarction, pulmonary embolism, or stroke.
✕. Has a history of bleeding disorder requiring hospitalization or systemic therapeutic intervention within the previous 3 months, or for participants without a prior kidney biopsy meeting eligibility criterion within the past 6 months who will require a biopsy during screening, any contraindication to kidney biopsy.
✕. Presence of clinically relevant (as assessed by the investigator) central nervous system (CNS) pathology such as epilepsy, seizure, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis; any BILAG A CNS manifestation within 4 weeks of enrollment.
✕. Any prior cellular therapies, obinutuzumab, anti-cluster of differentiation 19 (CD19) antibody, or B-cell targeting bispecific antibody, unless B-cells have recovered to baseline as assessed by the investigator. Investigational therapies or initiation of new SLE-directed therapies within 4 weeks.
✕. Severe kidney disease as assessed locally, defined as history of ISN/RPS Class VI or isolated Class V glomerulonephritis (without co existent/predominant Class III or IV glomerulonephritis) on renal biopsy.
✕. Known hypersensitivity to fludarabine or cyclophosphamide.