Status:
RECRUITING
A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
Lead Sponsor:
AstraZeneca
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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 wit...
Detailed Description
The study will enrol adult participants with refractory Systemic Lupus Erythematosus (SLE) The study will be run in 2 parts; First part is Phase 1b during which the study aims to assess safety and to...
Eligibility Criteria
Inclusion
- INCLUSION:
- 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:
- 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
Exclusion
Key Trial Info
Start Date :
April 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06897930
Start Date
April 21 2025
End Date
May 1 2029
Last Update
January 9 2026
Active Locations (8)
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1
Research Site
Tampa, Florida, United States, 33612
2
Research Site
Bethesda, Maryland, United States, 20892
3
Research Site
St Louis, Missouri, United States, 63110
4
Research Site
New York, New York, United States, 10032