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)
AstraZeneca
150 participants
Apr 21, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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.
Exclusion Criteria6
- 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
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Interventions
Single infusion of AZD0120 on visit DAY 1 after completing required lymphodepleting chemotherapy..
Lymphodepletion - specified dose prior to receiving AZD0120
Lymphodepletion - specified dose prior to receiving AZD0120
Locations(16)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06897930