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Lupus NephritisPhase 1NCT06429800

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

A Phase 1 study testing ATA3219 in people with Lupus Nephritis and Systemic Lupus Erythematosus, run by Atara Biotherapeutics at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Lupus Nephritis, Systemic Lupus Erythematosus
What is being tested?
ATA3219
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
16 Apr 2025to 16 Apr 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
Show all 19Show fewer
  • 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.
  • 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:
  • Has worsening LN (per criteria listed in [Gordon 2009]) while on treatment, OR
  • Has not achieved a complete renal response (CRR) after 2 or more lines of therapy, OR
  • Has not achieved a CRR after first-line therapy after a minimum of 12 months.
  • Hybrid SELENA-SLEDAI score of ≥ 8 points at screening
  • For participants with BILAG A involvement, this must include "clinical" hybrid SELENA-SLEDAI score of ≥ 4 points
  • For participants without BILAG A involvement, this must include clinical hybrid SELENA-SLEDAI score of ≥ 6 points
  • Meets BILAG-2004 criteria: At least 1 of the following:
  • BILAG-2004 level A disease in ≥ 1 organ system
  • BILAG-2004 level B disease in ≥ 2 organ systems and physician global assessment score ≥ 2
  • Persistent disease activity as defined in inclusion criterion #8 (above), despite having received 2 or more standard-of-care immunosuppressive therapies for SLE (as determined by the investigator), which may include biologics, for a minimum of 3 months (for participants with BILAG A involvement in any organ systems) or a minimum of 6 months (for participants with only BILAG B involvement in ≥ 2 organ systems).

Who cannot join

  • 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
  • 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.
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  • 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.
  • Any inability to discontinue or taper systemic SLE therapy prior to infusion of ATA3219, including
  • Tapering of corticosteroids to ≤ 10 mg/day and
  • Discontinuation of other systemic SLE therapies (including mycophenolate and/or voclosporin)
  • Severe kidney disease as assessed locally, defined as history of ISN/RPS Class III to IV on renal biopsy.
  • Contraindication to methylprednisolone 500 mg daily for 2 days.
  • Any inability to discontinue or taper systemic SLE therapy prior to infusion of ATA3219, including
  • Tapering of corticosteroids to ≤ 20 mg/day by Day -2, and
  • Suspension of other systemic SLE therapies (including mycophenolate and/or voclosporin)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Atara Biotherapeutics

    Thousand Oaks, California, 91320

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Being tested
ATA3219
Keywords
Lupus Nephritis (LN), Systemic Lupus Erythematosus (SLE), Anti CD19 Chimeric Antigen Receptor T cell (CAR T) Therapy, Human leukocyte antigen (HLA), Epstein-Barr virus (EBV) T cells, Extrarenal Systemic Lupus Erythematosus (ERL)
Medical subject headings
Lupus Nephritis, Lupus Erythematosus, Systemic, Epstein-Barr Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATA3219Drug

    ATA3219 is an allogeneic chimeric antigen receptor (CAR) T-cell therapy containing a second generation CD19 CAR construct in Epstein Barr virus (EBV) T cells, administered intravenously on Day 1.

Study groups in NCT06429800
Study groupRoleWhat they receive
Cohort LN: ATA3219 Dose Level -1ExperimentalParticipants will receive a single IV infusion of ATA3219 Dose Level -1 (if required) on Day 1 of a 28-day dose limiting toxicity (DLT) observation period.
Receives: Drug: ATA3219
Cohort LN: ATA3219 Dose Level 1ExperimentalParticipants will receive a single IV infusion of ATA3219 Dose Level 1 on Day 1 of a 28-day DLT observation period.
Receives: Drug: ATA3219
Cohort LN: ATA3219 Dose Level 2ExperimentalParticipants will receive a single IV infusion of ATA3219 Dose Level 2 on Day 1 of a 28-day DLT observation period.
Receives: Drug: ATA3219
Cohort LN: ATA3219 Dose Level 3ExperimentalParticipants will receive a single IV infusion of ATA3219 Dose Level 3 on Day 1 of a 28-day DLT observation period.
Receives: Drug: ATA3219
Cohort ERL: ATA3219 Dose Level -1ExperimentalParticipants will receive a single IV infusion of ATA3219 Dose Level -1 (if required) on Day 1 of a 28-day DLT observation period.
Receives: Drug: ATA3219
Cohort ERL: ATA3219 Dose Level 1ExperimentalParticipants will receive a single IV infusion of ATA3219 Dose Level 1 on Day 1 of a 28-day DLT observation period.
Receives: Drug: ATA3219
Cohort ERL: ATA3219 Dose Level 2ExperimentalParticipants will receive a single IV infusion of ATA3219 Dose Level 2 on Day 1 of a 28-day DLT observation period.
Receives: Drug: ATA3219
Cohort ERL: ATA3219 Dose Level 3ExperimentalParticipants will receive a single IV infusion of ATA3219 Dose Level 3 on Day 1 of a 28-day DLT observation period.
Receives: Drug: ATA3219

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With treatment-emergent adverse events, including adverse events of special interest

    Measured: From administration of pretreatments (LD or methylprednisolone) through 90 days after administration of study drug

  2. Number of Participants With Dose-limiting Toxicities

    Measured: Day 1 through Day 28 of first dose of study drug

  3. Maximum Tolerated dose

    Measured: Day 1 through Day 28 of first dose of study drug

  4. Recommended Phase 2 dose of ATA3219

    Measured: Day 1 through Day 28 of first dose of study drug

Secondary outcomes (22)

  1. Maximum Observed Plasma Concentration (Cmax) of ATA3219

    Measured: Pre-dose on Day 1 through 24 months after the last dose on a defined schedule

  2. Time to Reach Cmax (Tmax) of ATA3219

    Measured: Pre-dose on Day 1 through 24 months after the last dose on a defined schedule

  3. Partial Area Under the Curve (pAUC) of ATA3219

    Measured: Pre-dose on Day 1 through 24 months after the last dose on a defined schedule

  4. Last Observed Plasma Concentration (Clast) of ATA3219

    Measured: Pre-dose on Day 1 through 24 months after the last dose on a defined schedule

  5. Time of Clast of ATA3219

    Measured: Pre-dose on Day 1 through 24 months after the last dose on a defined schedule

  6. Terminal Half-life (t1/2) of ATA3219

    Measured: Pre-dose on Day 1 through 24 months after the last dose on a defined schedule

  7. Complete Renal Response

    Measured: Weeks 24 and 52

  8. Partial Renal Response

    Measured: Weeks 24 and 52

  9. Renal Objective Response Rate

    Measured: Weeks 24 and 52

  10. Change From Baseline in Urine protein-to-Creatinine Ratio

    Measured: Baseline (Day -5) through 24 months after the last dose on a defined schedule

  11. Change From Baseline in Estimated Glomerular Filtration Rate

    Measured: Baseline (Day -5) through 24 months after the last dose on a defined schedule

  12. Duration of Urine Protein-to-Creatinine ratio ≤ 0.5

    Measured: Baseline (Day -5) through 24 months after the last dose on a defined schedule

  13. Change From Baseline in Lupus Low Disease Activity State (LLDAS)

    Measured: Baseline (Day 28) through 24 months after the last dose on a defined schedule

  14. Change From Baseline in Definition of Remission in Systemic Lupus Nephritis (DORIS)

    Measured: Baseline (Day 28) through 24 months after the last dose on a defined schedule

  15. Change From Baseline in the Modified Version of the Safety of Estrogens in Lupus Erythematosus National Assessment version of the Systemic Lupus Nephritis Disease Activity (Hybrid SELENA-SLEDAI) Index

    Measured: Baseline (Day 28) through 24 months after the last dose on a defined schedule

  16. Change From Baseline in British Isles Lupus Assessment Group (BILAG) Index

    Measured: Baseline (Day 28) through 24 months after the last dose on a defined schedule

  17. Change From Baseline in SLE Responder Index (SRI)-4

    Measured: Baseline (Day 28) through 24 months after the last dose on a defined schedule

  18. Change From Baseline in BILAG-based Composite Lupus Assessment (BICLA) Response

    Measured: Baseline (Day 28) through 24 months after the last dose on a defined schedule

  19. Change From Baseline in Antibodies to Double Stranded Deoxyribonucleic Acid

    Measured: Baseline (Day -5) through 24 months after the last dose on a defined schedule

  20. Change From Baseline in Complement Component 3 (C3) and Complement Component 4 (C4) Levels

    Measured: Baseline (Day -5) through 24 months after the last dose on a defined schedule

  21. Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score

    Measured: Baseline (Day 28) through 24 months after the last dose on a defined schedule

  22. Number of Swollen and/or Tender Joints

    Measured: Baseline (Day 28) through 24 months after the last dose on a defined schedule

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2024
  2. Study start16 Apr 2025
  3. Primary completion16 Apr 2025
  4. Study completion16 Apr 2025

Why it stopped: Financial

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06429800
Sponsor's protocol ID
ATA3219-AEC-104
Status last verified
Apr 2025
First submitted
21 May 2024
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Petri M, Orbai AM, Alarcon GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473.

    PubMed 22553077

  • Gordon C, Jayne D, Pusey C, Adu D, Amoura Z, Aringer M, Ballerin J, Cervera R, Calvo-Alen J, Chizzolini C, Dayer J, Doria A, Ferrario F, Floege J, Guillevin L, Haubitz M, Hiepe F, Houssiau F, Lesavre P, Lightstone L, Meroni P, Meyer O, Moulin B, O'Reilly K, Praga M, Schulze-Koops H, Sinico R, Smith K, Tincani A, Vasconcelos C, Hughes G. European consensus statement on the terminology used in the management of lupus glomerulonephritis. Lupus. 2009 Mar;18(3):257-63. doi: 10.1177/0961203308100481.

    PubMed 19213865

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ATA3219 in people with Lupus Nephritis and Systemic Lupus Erythematosus, run by Atara Biotherapeutics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With treatment-emergent adverse events, including adverse events of special interest (time frame: From administration of pretreatments (LD or methylprednisolone) through 90 days after administration of study drug). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06429800, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.

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