AZD0120 for Lupus

Recruiting at 3 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

Must be taking: Immunosuppressants, Biologicals

Must not be taking: CAR T, CD19/BCMA

Disqualifiers: Active malignancy, Primary immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a new treatment called AZD0120 for individuals with Systemic Lupus Erythematosus (SLE), a condition where the immune system attacks healthy tissues. The study evaluates the safety and effectiveness of this treatment for those who have not responded well to standard treatments. Participants will receive a single dose of AZD0120, a therapy designed to target specific immune cells. This trial may suit someone diagnosed with SLE, who has tried at least two other treatments, and experiences significant symptoms like joint pain or skin rashes. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that AZD0120 is likely to be safe for humans?

Research shows that AZD0120, a new treatment using modified immune cells, is being tested for safety in people with hard-to-treat systemic lupus erythematosus (SLE). Earlier studies have shown promise for these types of treatments in helping people with SLE. They are usually well-tolerated but can cause side effects like fever, tiredness, and low blood cell counts.

This trial is in the early stages, focusing primarily on determining the safety of AZD0120 for use in people. Since it is still under investigation, detailed safety information is limited. However, reaching this stage suggests some safety in initial tests. It is always important to consult a doctor or healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for lupus, which typically involve immunosuppressants and corticosteroids, AZD0120 offers a novel approach by targeting specific pathways involved in the immune response. Researchers are excited about AZD0120 because it has the potential to modulate immune activity with greater precision, possibly leading to fewer side effects compared to traditional therapies. This could mean a more targeted treatment option, which might provide effective relief for lupus symptoms while minimizing the risk of broad immune suppression.

What evidence suggests that AZD0120 might be an effective treatment for Lupus?

Research shows that AZD0120, the investigational treatment in this trial, may benefit people with difficult-to-treat Systemic Lupus Erythematosus (SLE). Similar treatments have helped SLE patients who did not respond to other therapies. AZD0120 targets specific proteins on immune cells, potentially reducing inflammation and controlling the disease. Early results are promising, indicating it could be a viable option for managing challenging SLE cases. Although further research is necessary, these initial findings offer hope for those with severe SLE. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults aged 18-70 with refractory Systemic Lupus Erythematosus (SLE) who've tried at least two standard immunosuppressants, including a biological agent, and have significant SLE-related organ involvement. Participants must have had prior CAR T therapy, be willing to follow the study schedule, and have good liver, kidney, lung, and heart function.

Inclusion Criteria

SLEDAI-2K score ≥6 at screening

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

Exclusion Criteria

Primary immunodeficiency

I have received treatment targeting CD19 or BCMA.

I have previously undergone CAR T therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b

Assessment of safety and tolerability of AZD0120 in patients with refractory SLE

2 years

Phase 2

Assessment of safety, tolerability, and efficacy of the selected dose of AZD0120 in patients with refractory SLE

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AZD0120

Trial Overview The trial is testing AZD0120 in combination with Cyclophosphamide and Fludarabine. It's an open-label study where all participants receive the same treatment to assess its safety and effectiveness against severe lupus symptoms that haven't responded to other treatments.

How Is the Trial Designed?

Group I: AZD0120 Experimental Treatment 3 Interventions

Single dose of AZD0120

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

1. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D8313C00001

A study to investigate the safety, tolerability, and efficacy of ... A study to investigate the safety, tolerability, and efficacy of AZD0120 in adults with Refractory SLE. Study identifier:D8313C00001. ClinicalTrials.gov ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S004901722500157X

CAR T-cell therapy in SLE: A systematic review We conducted a systematic review to evaluate all clinical studies assessing safety and efficacy outcomes of CAR therapy in SLE.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06897930?term=AREA[BasicSearch](antigen%20specific%20systemic%20lupus)&rank=1

NCT06897930 | A Study to Investigate the Safety, ... 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 ...

4. acrabstracts.org acrabstracts.org/abstract/cd19-bcma-dual-targeting-fastcar-t-cells-gc012f-azd0120-in-patients-with-refractory-systemic-lupus-erythematosusm-an-open-label-single-center-phase-i-study/

CD19/BCMA Dual-Targeting FasTCAR-T Cells GC012F ... CD19/BCMA Dual-Targeting FasTCAR-T Cells GC012F (AZD0120) in patients with refractory Systemic Lupus Erythematosusm: an open-label, single-center Phase I study.

5. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/587435

The D8313C00001 study is testing AZD0120 in adults who ... The D8313C00001 study is testing AZD0120 in adults who have Systemic Lupus Erythematosus (SLE) that has not responded well to prior treatments.

6. astrazeneca.com astrazeneca.com/our-therapy-areas/pipeline.html

Pipeline Our pipeline forms a robust portfolio of investigational therapies in varied stages of clinical development.