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Lupus Erythematosus, SystemicPhase 1/2NCT06897930

A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE

A Phase 1/2 study testing AZD0120, Cyclophosphamide and Fludarabine in people with Lupus Erythematosus, Systemic, run by AstraZeneca at 20 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a Phase 1b/2, single-arm, open-label, multi-center, clinical study of AZD0120, a CD19/BCMA dual CAR T cell therapy, to evaluate the safety, tolerability, and efficacy in adult participants with refractory Systemic Lupus Erythematosus. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
AZD0120, Cyclophosphamide and Fludarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
20 sitesin 4 countries
Study dates
21 Apr 2025to 1 May 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females aged 18 through 70 years inclusive at the time of consent.
  • Written informed consent in accordance with federal, local, and institutional guidelines.
  • Must be able and willing to adhere to the study visit schedule and other protocol requirements
  • Adequate hepatic, renal, pulmonary, and cardiac function
  • Have a clinical diagnosis of SLE according to the EULAR/ American College of Rheumatology (ACR) 2019 criteria with a positive ANA ≥1:80 and a score ≥10.
  • Have used at least two standard immunosuppressants (including one biological agent).
Show all 9Show fewer
  • SLEDAI-2K score ≥6 at screening.
  • Must include a significant SLE related organ involvement: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal.
  • For lupus nephritis: Diagnosis of proliferative lupus nephritis based on a renal biopsy obtained within 6 months prior to signing the informed consent form or during the screening period Class III, IV or V LN according to the WHO 2003 ISN/RPS classification.

Who cannot join

  • Have received prior treatment with CAR T therapy directed at any target.
  • Have received any therapy that is targeted to CD19 and/or BCMA
  • Received allogenic stem cell transplant or autologous stem cell transplant.
  • An active malignancy that is progressing or requires active treatment.
  • Primary immunodeficiency
  • Active viral or bacterial infection

Trial locations and contacts

20 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

20 sites in 4 countries

United States16 sites, 14 recruiting

  • Research Site

    Atlanta, Georgia, 30322

    Recruiting

  • Research Site

    Baltimore, Maryland, 21287

    Not yet recruiting

  • Research Site

    Bethesda, Maryland, 20892

    Withdrawn

  • Research Site

    Boston, Massachusetts, 02115

    Recruiting

  • Research Site

    Chapel Hill, North Carolina, 27599-7280

    Recruiting

  • Research Site

    Charlotte, North Carolina, 28204

    Recruiting

  • Research Site

    Chicago, Illinois, 60611

    Not yet recruiting

  • Research Site

    New York, New York, 10032

    Recruiting

  • Research Site

    Richmond, Virginia, 23298

    Not yet recruiting

  • Research Site

    San Francisco, California, 94143

    Recruiting

  • Research Site

    Seattle, Washington, 98104

    Recruiting

  • Research Site

    Seattle, Washington, 98195

    Recruiting

  • Research Site

    St Louis, Missouri, 63110

    Recruiting

  • Research Site

    Stanford, California, 94304-2201

    Not yet recruiting

  • Research Site

    Syracuse, New York, 13202-2240

    Recruiting

  • Research Site

    Tampa, Florida, 33612

    Suspended

Other trials in United States

Australia2 sites, 2 recruiting

  • Research Site

    Darlinghurst, 2010

    Recruiting

  • Research Site

    Melbourne, 3000

    Not yet recruiting

Other trials in Australia

Canada1 site, 1 recruiting

  • Research Site

    Toronto, M5T 2S8

    Not yet recruiting

Other trials in Canada

United Kingdom1 site, 1 recruiting

  • Research Site

    Bristol, BS1 3NU

    Not yet recruiting

Other trials in United Kingdom

About this study

Official title: A Phase 1b/2 Study of AZD0120, a Chimeric Antigen Receptor T-cell (CAR T) Therapy Targeting CD19 and B-cell Maturation Antigen (BCMA) in Subjects With Refractory Systemic Lupus Erythematosus (SLE)

This is a Phase 1b/2, single-arm, open-label, multi-center, clinical study of AZD0120, a CD19/BCMA dual CAR T cell therapy, to evaluate the safety, tolerability, and efficacy in adult participants with refractory Systemic Lupus Erythematosus.

Read the detailed description

The study will enrol adult participants with refractory Systemic Lupus Erythematosus (SLE) The study will be run in 2 parts;

First part is Phase 1b during which the study aims to assess safety and tolerability of AZD0120 in patients in refractory SLE cohorts

Second part is Phase 2, during which the study aims to assess safety, tolerability and efficacy of the selected dose, following Phase 1b completion, in patients with refractory SLE

Being tested
AZD0120, Cyclophosphamide, Fludarabine
Keywords
AZD0120, SLE, Systemic Lupus Erythematosus, Lupus, Lupus Nephritis
Medical subject headings
Lupus Erythematosus, Systemic, Lupus Nephritis

What participants receive

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

  • AZD0120Biological

    Also called GC012F

    Single infusion of AZD0120 on visit DAY 1 after completing required lymphodepleting chemotherapy..

  • CyclophosphamideDrug

    Lymphodepletion - specified dose prior to receiving AZD0120

  • FludarabineDrug

    Lymphodepletion - specified dose prior to receiving AZD0120

Study groups in NCT06897930
Study groupRoleWhat they receive
AZD0120ExperimentalSingle dose of AZD0120
Receives: Biological: AZD0120; Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

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

  1. PHASE 1B: To evaluate the safety and tolerability of AZD0120 in participants with refractory systemic lupus erythematosus (SLE)

    The incidence and severity of adverse events (AEs)

    Measured: 2 years

  2. PHASE 1B: Recommended Phase 2 Dose (RP2D) of AZD0120 in for Phase 2

    To determine the recommended phase 2 dose (RP2D) of AZD0120

    Measured: 2 years

  3. PHASE 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE

    Proportion of participants achieving SRI-4 response

    Measured: 2 years

Secondary outcomes (17)

  1. PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE

    Proportion of participants achieving SLE Responder Index 4 (SRI-4) response over time

    Measured: 2 years

  2. PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE

    Proportion of participants achieving remission in SLE (DORIS) remission over time

    Measured: 2 years

  3. PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE

    Proportion of participants achieving Lupus Low Disease Activity State (LLDAS) over time

    Measured: 2 years

  4. PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE

    Proportion of participants achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response over time

    Measured: 2 years

  5. PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE

    Time from AZD0120 infusion and time from response to first disease flare

    Measured: 2 years

  6. PHASE 1B & 2: To characterize the cellular kinetics of AZD0120 in participants with refractory SLE

    The area under the concentration-time curve (AUC) from time zero (T0) to the last measurable concentration time point (AUClast)

    Measured: 2 years

  7. PHASE 1B & 2: To characterize the cellular kinetics of AZD0120 in participants with refractory SLE

    Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))

    Measured: 2 years

  8. PHASE 1B & 2: To characterize the cellular kinetics of AZD0120 in participants with refractory SLE

    The last measurable concentration of AZD0120 (Clast)

    Measured: 2 years

  9. PHASE 1B & 2: To characterize the cellular kinetics of AZD0120 in participants with refractory SLE

    Maximum observed blood concentration (Cmax)

    Measured: 2 years

  10. PHASE 1B & 2: To characterize the cellular kinetics of AZD0120 in participants with refractory SLE

    Terminal half-life of a drug during its elimination phase in pharmacokinetics (t1/2λz)

    Measured: 2 years

  11. PHASE 1B & 2: To characterize the cellular kinetics of AZD0120 in participants with refractory SLE

    Time of the last measurable (quantifiable) concentration of a AZD0120 (Tlast)

    Measured: 2 years

  12. PHASE 1B & 2: To characterize the cellular kinetics of AZD0120 in participants with refractory SLE

    Time of maximum observed blood concentration (Tmax)

    Measured: 2 years

  13. PHASE 1B & 2: To assess immunogenicity of AZD0120

    Presence of AZD0120 antibodies

    Measured: 2 years

  14. PHASE 1B & 2: To determine whether replication-competent lentivirus is present in participants that receive AZD0120

    Presence of replication-competent lentivirus (RCL)

    Measured: 2 years

  15. PHASE 2: To further characterize the safety of AZD0120 in participants with refractory SLE

    Further characterization of the safety of AZD0120 by measuring the incidence and severity of Treatment Emergent Adverse Events (TEAEs)

    Measured: 2 years

  16. PHASE 2: To assess changes from baseline for reported health-related quality of life, overall health status

    To assess changes from baseline for Changes in Lupus Quality of life (LupusQoL)

    Measured: 2 years

  17. PHASE 2: To assess changes from baseline for reported health-related quality of life, overall health status

    To assess changes from baseline for FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY (FACIT)

    Measured: 2 years

Timeline

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

  1. First posted27 Mar 2025
  2. Study start21 Apr 2025
  3. Primary completion1 May 2029 (estimated)
  4. Study completion1 May 2029 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Drug: AZD0120 Single infusion of AZD0120
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06897930
Sponsor's protocol ID
D8313C00001
Status last verified
Sep 2026
First submitted
12 Mar 2025
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AZD0120, Cyclophosphamide and Fludarabine in people with Lupus Erythematosus, Systemic, run by AstraZeneca at 20 sites in 4 countries.

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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Australia, Canada, United Kingdom. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PHASE 1B: To evaluate the safety and tolerability of AZD0120 in participants with refractory systemic lupus erythematosus (SLE) (time frame: 2 years). The study lists 3 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 NCT06897930.

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 10 Sep 2026.

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