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RecruitingNCT06897930Updated Sep 10, 2026

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

A Phase 1/2 interventional study of AZD0120 and Cyclophosphamide in Lupus Erythematosus, Systemic, sponsored by AstraZeneca. Recruiting at 20 sites in 4 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by AstraZeneca · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 5 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Lupus Erythematosus, Systemic

Keywords

  • AZD0120
  • SLE
  • Systemic Lupus Erythematosus
  • Lupus
  • Lupus Nephritis
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 150 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Males or females aged 18 through 70 years inclusive at the time of consent.
  2. Written informed consent in accordance with federal, local, and institutional guidelines.
  3. Must be able and willing to adhere to the study visit schedule and other protocol requirements
  4. Adequate hepatic, renal, pulmonary, and cardiac function
  5. 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.
  6. Have used at least two standard immunosuppressants (including one biological agent).
  7. SLEDAI-2K score ≥6 at screening.
  8. Must include a significant SLE related organ involvement: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal.
  9. 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.

Exclusion criteria

EXCLUSION:

  1. Have received prior treatment with CAR T therapy directed at any target.
  2. Have received any therapy that is targeted to CD19 and/or BCMA
  3. Received allogenic stem cell transplant or autologous stem cell transplant.
  4. An active malignancy that is progressing or requires active treatment.
  5. Primary immunodeficiency
  6. Active viral or bacterial infection
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    AZD0120

    Single dose of AZD0120

    Biological: AZD0120 · Drug: Cyclophosphamide · Drug: Fludarabine

Interventions

  • BiologicalAZD0120

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

    Also known as: GC012F

  • DrugCyclophosphamide

    Lymphodepletion - specified dose prior to receiving AZD0120

  • DrugFludarabine

    Lymphodepletion - specified dose prior to receiving AZD0120

06

What researchers measure

Primary outcomes

  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)

    Time frame: 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

    Time frame: 2 years

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

    Proportion of participants achieving SRI-4 response

    Time frame: 2 years

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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))

    Time frame: 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)

    Time frame: 2 years

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

    Maximum observed blood concentration (Cmax)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 2 years

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

    Presence of AZD0120 antibodies

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 2 years

07

Study locations

11 of 20 sites recruiting
  • Research Site
    San Francisco, California 94143, United States
    Recruiting
  • Research Site
    Stanford, California 94304-2201, United States
    Not yet recruiting
  • Research Site
    Tampa, Florida 33612, United States
    Suspended
  • Research Site
    Atlanta, Georgia 30322, United States
    Recruiting
  • Research Site
    Chicago, Illinois 60611, United States
    Not yet recruiting
  • Research Site
    Baltimore, Maryland 21287, United States
    Not yet recruiting
  • Research Site
    Bethesda, Maryland 20892, United States
    Withdrawn
  • Research Site
    Boston, Massachusetts 02115, United States
    Recruiting
  • Research Site
    St Louis, Missouri 63110, United States
    Recruiting
  • Research Site
    New York, New York 10032, United States
    Recruiting
  • Research Site
    Syracuse, New York 13202-2240, United States
    Recruiting
  • Research Site
    Chapel Hill, North Carolina 27599-7280, United States
    Recruiting
  • Research Site
    Charlotte, North Carolina 28204, United States
    Recruiting
  • Research Site
    Richmond, Virginia 23298, United States
    Not yet recruiting
  • Research Site
    Seattle, Washington 98104, United States
    Recruiting
  • Research Site
    Seattle, Washington 98195, United States
    Recruiting
  • Research Site
    Darlinghurst, 2010, Australia
    Recruiting
  • Research Site
    Melbourne, 3000, Australia
    Not yet recruiting
  • Research Site
    Toronto, M5T 2S8, Canada
    Not yet recruiting
  • Research Site
    Bristol, BS1 3NU, United Kingdom
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06897930
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Mar 27, 2025
Start date
Apr 21, 2025
Primary completion
May 1, 2029 (estimated)
Completion
May 1, 2029 (estimated)
Last update
Sep 10, 2026

Study contacts

AstraZeneca Clinical Study Information Center
Contact
information.center@astrazeneca.com
1-877-240-9479

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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