AZD0120 for Rheumatoid Arthritis

(AURORA Trial)

Not yet recruiting at 9 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Fludarabine, Cyclophosphamide

Disqualifiers: Prior CAR T, Transplant, Hypertension, Malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests AZD0120, a potential new drug for difficult-to-treat rheumatoid arthritis, systemic sclerosis (a condition causing skin thickening), and idiopathic inflammatory myopathies (muscle inflammation with unknown causes). Researchers aim to determine the safety of AZD0120 and its effects on these conditions. The trial includes two different treatment plans to identify the most effective one. Candidates who have struggled with these conditions, can travel to the study site, and meet other health requirements may be suitable participants. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects on people.

Will I have to stop taking my current medications?

The trial mentions a 'washout period' (time without taking certain medications), so you may need to stop some of your current medications before participating. However, the specific medications that require stopping are not detailed in the information provided.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AZD0120, a therapy using modified immune cells, is being tested in individuals with conditions like systemic lupus erythematosus. Early results suggest it is generally safe. Some participants have experienced mild to moderate side effects, common in early trials, such as tiredness, fever, or low blood cell counts. As this trial is in an early stage, the primary goal is to assess its safety. The treatment remains under study, and more safety information will emerge as additional participants join the trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about AZD0120 for rheumatoid arthritis because it offers a potentially new way to manage this condition. Unlike traditional treatments like methotrexate or biologics that target specific immune pathways, AZD0120 introduces a novel mechanism of action by focusing on different immune system targets. This could mean improved efficacy for patients who haven't had success with existing options. Additionally, AZD0120 is administered via infusion, which might provide more consistent dosing and potentially faster relief.

What evidence suggests that this trial's treatments could be effective for difficult-to-treat rheumatoid arthritis?

Research has shown that AZD0120, a new type of therapy, produced promising results in early studies. Patients with severe rheumatic diseases improved without needing additional immune-modulating drugs. This suggests that AZD0120 may effectively target and reduce harmful immune cells. While most data comes from similar conditions, the treatment demonstrated significant success in early tests, particularly in multiple myeloma, a cancer affecting the bone marrow. This trial will test two different regimens of AZD0120 to evaluate its effectiveness for difficult-to-treat rheumatoid arthritis. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with certain autoimmune diseases: systemic sclerosis, necrotizing myositis, or rheumatoid arthritis that's hard to treat. Participants must meet specific health criteria not detailed here.

Inclusion Criteria

I can sign and understand the consent form.

Willingness to remain on/start appropriate, highly effective methods of birth control or other acceptable criteria

My body's systems are functioning well enough for treatment.

Exclusion Criteria

I have a history of cancer or am currently being treated for one, but some cancers may be acceptable.

I don't have any brain conditions that could make the trial unsafe for me.

I have a genetic immune system disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an infusion of AZD0120 Regimen 1 or Regimen 2

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• AZD0120

Trial Overview

The study tests AZD0120, a new therapy using modified T-cells targeting two proteins often found in these diseases. It's an early-phase trial to see if it's safe and how well participants can tolerate it.

How Is the Trial Designed?

Group I: AZD0120 Regimen 2 Experimental Treatment 1 Intervention

Participants will receive an infusion of AZD0120 Regimen 2.

Group II: AZD0120 Regimen 1 Experimental Treatment 1 Intervention

Participants will receive an infusion of AZD0120 Regimen 1.

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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07295847

A Study of AZD0120 in Autoimmune Diseases

This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12485509/

Innovations in immunotherapy for autoimmune diseases

Among the most widely used are IL-6 inhibitors, such as tocilizumab and sarilumab, which have demonstrated clinical efficacy in rheumatoid ...

3.

eurekalert.org

eurekalert.org/news-releases/1087307

Cell-depleting treatment in severe RMD: New data

Data from patients with at least 1-month follow-up demonstrate early immunomodulatory-free clinical responses and a favourable safety profile.

4.

astrazenecaclinicaltrials.com

astrazenecaclinicaltrials.com/study/D8313C00001

Study: AZD0120 Safety, Tolerability, Efficacy in Refractory SLE

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 ...

5.

delta.larvol.com

delta.larvol.com/Products/?ProductId=31f0710d-3987-4966-ab48-cf7397887347

AZD0120 / AstraZeneca

AZD0120 (GC012F), a BCMA/CD19 dual-targeting fastcar T-cell therapy, demonstrates potent preclinical efficacy in multiple myeloma (ASH 2025) - "The ...

6.

astrazeneca.com

astrazeneca.com/content/astraz/what-science-can-do/topics/next-generation-therapeutics/immunology-cell-therapy.html

Aiming to reset the immune system to transform immunology

Preliminary results of CD19/BCMA Dual-Targeting FasTCAR-T Cells GC012F (AZD0120) in patients with refractory Systemic Lupus Erythematosus-an ...

7.

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.

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06897930

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 ...