AZD0120 for Refractory Systemic Lupus Erythematosus
A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
Recruiting
Phase 1Phase 2Interventional Study
Lupus Erythematosus, Systemic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for adults aged 18 to 70 who have severe systemic lupus erythematosus that hasn’t improved with other treatments. Participants will receive a special therapy called AZD0120 and will be monitored for its safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 70 years old.
I have been diagnosed with systemic lupus erythematosus.
I have taken at least two standard immunosuppressants.
I have a SLEDAI-2K score of 6 or higher.
I have at least one significant SLE-related organ issue.
I can keep up with study visits and protocol requirements.
I have normal liver, kidney, lung, and heart function.
I have a positive ANA test.
You may not be able to join if
I have had CAR T therapy before.
I have received treatment aimed at CD19 or BCMA.
I have had a stem cell transplant.
I currently have an active cancer that needs treatment.
I have a primary immunodeficiency.
I have an active viral or bacterial infection.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 Locations
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Eligibility Criteria
INCLUSION:
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 hepati…
INCLUSION:
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:
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
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