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NCT06897930PHASE1, PHASE2Recruiting

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

AstraZeneca

Start Date

4/21/2025

Completion Date

5/1/2029

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.

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 tolerability of AZD0120 in patients in refractory SLE cohorts Second part is Phase 2, during which the study aims to assess safety, tolerability and efficacy of the selected dose, following Phase 1b completion, in patients with refractory SLE

Eligibility Criteria

Age Range: 18 years to 70 years

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

Interventions

BIOLOGICAL

AZD0120

DRUG

Cyclophosphamide

DRUG

Fludarabine

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Conditions

Lupus Erythematosus, Systemic

Locations

Research Site

San Francisco, California 94143

United States

Research Site

Stanford, California 94304-2201

United States

Research Site

Tampa, Florida 33612

United States

Research Site

Atlanta, Georgia 30322

United States

Research Site

Chicago, Illinois 60611

United States

Research Site

Bethesda, Maryland 20892

United States

Research Site

Boston, Massachusetts 02115

United States

Research Site

St Louis, Missouri 63110

United States

Research Site

New York, New York 10032

United States

Research Site

Syracuse, New York 13202-2240

United States

Research Site

Chapel Hill, North Carolina 27599-7280

United States

Research Site

Charlotte, North Carolina 28204

United States

Research Site

Richmond, Virginia 23298

United States

Research Site

Seattle, Washington 98104

United States

Research Site

Seattle, Washington 98195

United States

Research Site

Darlinghurst, 2010

Australia

Research Site

Melbourne, 3000

Australia

Research Site

Toronto, M5T 2S8

Canada