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Recruiting Phase 1/2

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

NCT06897930 · tracked via the Priya Life Science UK tracker
Phase
Phase 1/2
Started
2025-04-21
Last updated
2026-09-10

Condition(s) studied

Lupus Erythematosus, Systemic

Investigational drug(s) / intervention(s)

AZD0120 →Cyclophosphamide →Fludarabine →

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

Cyclophosphamide: Lymphodepletion - specified dose prior to receiving AZD0120

Fludarabine: Lymphodepletion - specified dose prior to receiving AZD0120

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • PHASE 1B: To evaluate the safety and tolerability of AZD0120 in participants with refractory systemic lupus erythematosus (SLE) — 2 years
    The incidence and severity of adverse events (AEs)
  • PHASE 1B: Recommended Phase 2 Dose (RP2D) of AZD0120 in for Phase 2 — 2 years
    To determine the recommended phase 2 dose (RP2D) of AZD0120
  • PHASE 2: To evaluate the efficacy of AZD0120 in participants with refractory SLE — 2 years
    Proportion of participants achieving SRI-4 response

Trial sites (20)

FacilityCityRegionStatus
Research Site San Francisco California Recruiting
Research Site Stanford California Not Yet Recruiting
Research Site Tampa Florida Suspended
Research Site Atlanta Georgia Recruiting
Research Site Chicago Illinois Not Yet Recruiting
Research Site Baltimore Maryland Not Yet Recruiting
Research Site Bethesda Maryland Withdrawn
Research Site Boston Massachusetts Recruiting
Research Site St Louis Missouri Recruiting
Research Site New York New York Recruiting
Research Site Syracuse New York Recruiting
Research Site Chapel Hill North Carolina Recruiting
Research Site Charlotte North Carolina Recruiting
Research Site Richmond Virginia Not Yet Recruiting
Research Site Seattle Washington Recruiting
Research Site Seattle Washington Recruiting
Research Site Darlinghurst Australia Recruiting
Research Site Melbourne Australia Not Yet Recruiting
Research Site Toronto Canada Not Yet Recruiting
Research Site Bristol United Kingdom Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06897930 on ClinicalTrials.gov ↗ ← All trials in the UK