A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
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)
1 other identifier
interventional
150
2 countries
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2025
Longer than P75 for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2025
CompletedFirst Posted
Study publicly available on registry
March 27, 2025
CompletedStudy Start
First participant enrolled
April 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
April 8, 2026
February 1, 2026
4 years
March 12, 2025
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
2 years
PHASE 1B: Recommended Phase 2 Dose (RP2D) of AZD0120 in for Phase 2
To determine the recommended phase 2 dose (RP2D) of AZD0120
2 years
PHASE 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE
Proportion of participants achieving SRI-4 response
2 years
Secondary Outcomes (17)
PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE
2 years
PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE
2 years
PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE
2 years
PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE
2 years
PHASE 1B & 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE
2 years
- +12 more secondary outcomes
Study Arms (1)
AZD0120
EXPERIMENTALSingle dose of AZD0120
Interventions
Single infusion of AZD0120 on visit DAY 1 after completing required lymphodepleting chemotherapy..
Eligibility Criteria
You may qualify if:
- 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).
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (16)
Research Site
San Francisco, California, 94143, United States
Research Site
Stanford, California, 94304-2201, United States
Research Site
Tampa, Florida, 33612, United States
Research Site
Atlanta, Georgia, 30322, United States
Research Site
Bethesda, Maryland, 20892, United States
Research Site
Boston, Massachusetts, 02115, United States
Research Site
St Louis, Missouri, 63110, United States
Research Site
New York, New York, 10032, United States
Research Site
Syracuse, New York, 13202-2240, United States
Research Site
Chapel Hill, North Carolina, 27599-7280, United States
Research Site
Charlotte, North Carolina, 28204, United States
Research Site
Richmond, Virginia, 23298, United States
Research Site
Seattle, Washington, 98104, United States
Research Site
Seattle, Washington, 98195, United States
Research Site
Darlinghurst, 2010, Australia
Research Site
Melbourne, 3000, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2025
First Posted
March 27, 2025
Study Start
April 21, 2025
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
May 1, 2029
Last Updated
April 8, 2026
Record last verified: 2026-02