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Investigating AZD0120 for treating adults with refractory lupus

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)

Phase1; Phase2 Interventional AstraZeneca · NCT06897930

This study is testing a new treatment called AZD0120 to see if it can help adults with hard-to-treat lupus feel better.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsCAR T
Locations18 sites (San Francisco, California and 17 other locations)
Trial IDNCT06897930 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and efficacy of AZD0120, a dual CAR T cell therapy, in adults with refractory Systemic Lupus Erythematosus (SLE). The study is divided into two phases: Phase 1b focuses on assessing safety and tolerability, while Phase 2 aims to evaluate the efficacy of the selected dose after Phase 1b completion. Participants will receive AZD0120 along with other treatments like Cyclophosphamide and Fludarabine. The trial is multi-center and open-label, allowing for a comprehensive assessment of the therapy's effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a clinical diagnosis of refractory SLE who have not responded to standard immunosuppressants.

Not a fit: Patients with mild SLE or those who have not previously used standard immunosuppressants may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from refractory SLE.

How similar studies have performed: Other studies have shown promise with CAR T cell therapies in autoimmune conditions, suggesting potential for success in this novel approach.

Eligibility criteria

Show full inclusion / exclusion 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 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

Where this trial is running

San Francisco, California and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lupus Erythematosus, SystemicAZD0120SLESystemic Lupus ErythematosusLupusLupus Nephritis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.