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A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Systemic Lupus Erythematosus | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Systemic Lupus Erythematosus

A Phase 1 Study to Evaluate the Safety and Preliminary Efficacy of ATA3219, Allogeneic Anti-CD19 Chimeric Antigen Receptor T-cell (CAR T) Therapy, in Subjects With Systemic Lupus Erythematosus

NCT06429800•Atara Biotherapeutics

View on ClinicalTrials.gov

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.

Detailed Description

This is a Phase 1, multi-centered, open-labeled, dose escalation study to evaluate the safety and preliminary efficacy of ATA3219 (as monotherapy) in participants with LN following LD (Cohort LN) and in participants with extrarenal SLE (ERL) without LD (Cohort ERL). This study is planned to be conducted in the United States, Canada, and Australia. For each cohort, up to 3 dose levels (DLs) will be explored in the dose escalation portion of the study and if needed a lower dose may be explored. Prior to undergoing any screening procedure, prospective participants must undergo the ATA3219 inventory check assessments to ensure availability of an appropriate partially human leukocyte antigen (HLA)-matched ATA3219 product lot. Before administration of ATA3219, participants will receive LD treatment (Cohort LN) or methylprednisolone treatment (Cohort ERL). For all enrolled participants, hospitalization during and following ATA3219 dosing is mandatory. Participants will receive a single dose intravenous (IV) infusion of ATA3219 (monotherapy) on Day 1. Participants will remain inpatient for a minimum of 1 week post ATA3219 dosing, where they will be frequently monitored. Clinical responses will be assessed by the investigator on Day 28 (+ 5 days) following each dose of ATA3219. For each cohort, during dose escalation, up to 3 DLs of ATA3219 are planned to be evaluated sequentially and a lower dose may be added. At least 3 and up to 6 dose-limiting toxicity (DLT)-evaluable participants, those who complete the 28-day DLT observation period, will be assessed at each DL. Within each DL, treatment will be staggered to allow appropriate safety monitoring by an independent Data Safety Monitoring Committee (DSMC). Enrolled participants who do not receive ATA3219 for any cause (e.g., rapid deterioration) will be replaced. Participants who experience an adverse event (AE) during the 28-day DLT observation and complete the observation period will not be replaced. In addition, if a participant is treated with ATA3219 and discontinues for any reason other than due to a DLT prior to completing the 28-day DLT observation period, an additional participant may be enrolled at the dose level to ensure that the recommended phase 2 dose (RP2D) can be determined, with a goal not to exceed 6 participants treated/dose level. In rare situations, retreatment of participants with inadequate renal response may be considered. After treatment is completed or discontinued, participants will be followed for safety and clinical response for up to 24 months from the last dose of ATA3219. A separate long-term follow-up study will be conducted to follow participants for up to a total of 15 years after their last dose of ATA3219.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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 \[Petri 2012\].
•2. Meets one or more of the following immunologic criteria during screening:
•1. Anti double stranded DNA above laboratory reference range, except enzyme linked immunosorbent assay (2 × above laboratory reference range), OR
•2. Presence of one or more of following autoantibodies: anti-Smith, anti-ribonucleoprotein, or anti-phospholipid, OR
•3. Low complement as demonstrated by low complement component 3, low complement component 4, or low complement CH50.
•3. Adequate lung, liver, kidney, and cardiac function.
•4. 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.
•5. Proteinuria level between ≥ 1.0 to 6.0 g/g via urine protein creatinine ratio during screening.
•6. Has refractory LN defined as having received 1 or more standard therapies for LN (which must have included mycophenolate mofetil, mycophenolic acid, or cyclophosphamide), and:
•1. Has worsening LN (per criteria listed in \[Gordon 2009\]) while on treatment, OR
+9 more criteria

Exclusion Criteria

•1. Has a concurrent systemic autoimmune disease that may confound study assessments other than SLE, LN, or cutaneous lupus erythematosus.
•2. Has any unstable or progressive manifestation of SLE that is likely to warrant an intensification of lupus-directed therapy
•3. 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.
•4. 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.
•5. 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.
•6. 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.
•7. 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.
•8. Known hypersensitivity to fludarabine or cyclophosphamide.
•9. Any inability to discontinue or taper systemic SLE therapy prior to infusion of ATA3219, including
•1. Tapering of corticosteroids to ≤ 10 mg/day and
+6 more criteria

Locations (1)

Atara Biotherapeutics

Thousand Oaks, California, United States

Key Dates

Start Date

April 16, 2025

Primary Completion Date

April 16, 2025

Completion Date

April 16, 2025

Last Updated

April 24, 2025

Conditions

Lupus NephritisSystemic Lupus Erythematosus

Interventions

ATA3219

DRUG

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Systemic Lupus Erythematosus

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH

Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus