AZD0120 for Multiple Sclerosis

(ZENITH Trial)

Not yet recruiting at 7 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: AstraZeneca
Must be taking: High efficacy DMT
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD0120, an experimental therapy for individuals with Multiple Sclerosis (MS), specifically targeting those with relapsing or progressive MS. The main goal is to assess the treatment's safety and understand its processing in the body. The trial divides participants into two groups: one for relapsing MS and another for progressive MS. Those who have experienced recent relapses or have not responded well to other treatments might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking 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 team or your doctor.

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

Research shows that AZD0120 is in the early stages of testing, primarily to assess its safety in humans. This cell therapy targets specific proteins associated with multiple sclerosis. Although detailed information about its safety in humans is limited, the current testing phase focuses on evaluating how well participants tolerate the treatment and identifying any side effects.

Researchers closely monitor participants for any unwanted effects, known as adverse events. As this is an early-stage trial, the primary goal is to ensure the treatment's safety before proceeding to larger studies. So far, no major data on side effects has been shared, and the safety of AZD0120 remains under investigation.12345

Why do researchers think this study treatment might be promising for Multiple Sclerosis?

AZD0120 is unique because it targets multiple sclerosis in a novel way by specifically focusing on different types of the disease, including relapsing and progressive forms. Unlike standard treatments like interferons and monoclonal antibodies, which mainly aim to reduce inflammation or modulate the immune system, AZD0120 may offer a new mechanism of action that addresses the underlying disease process. Researchers are excited because this could mean more effective management of symptoms and potentially slowing disease progression, offering hope for patients who have limited options with current therapies.

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

Research has shown that AZD0120, a new type of cell therapy, may help treat multiple sclerosis. Early study results suggest it works well and is safe, with no reported cases of brain swelling. This indicates the treatment might effectively target and reduce harmful cells in the body. In this trial, participants will receive AZD0120, with one group focusing on relapsing-remitting multiple sclerosis (RMS) and another on progressive multiple sclerosis (PMS). For individuals with severe relapsing-remitting multiple sclerosis (RRMS), treatments like AZD0120 have led to stable remission and significant improvement over two years. While more information about AZD0120's effects on multiple sclerosis is still being gathered, these early signs are promising.23678

Are You a Good Fit for This Trial?

Adults with Multiple Sclerosis can join this trial. Specific details about who can and cannot participate are not provided, but typically participants need to meet certain health criteria.

Inclusion Criteria

Written informed consent in accordance with federal, local, and institutional guidelines
Participants should have an EDSS of ≤ 6.5 at screening
My body's systems are functioning well enough for treatment.
See 6 more

Exclusion Criteria

I do not have serious heart conditions that would make the trial unsafe for me.
Participant has significant psychiatric condition (active or history of)
Seropositive for HIV
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy

4 weeks
Multiple visits for administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

104 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AZD0120
Trial Overview The study is testing AZD0120, a new CAR+ T-cell therapy targeting two proteins (BCMA/CD19), in two different dosing regimens to see how safe and tolerable it is for treating Multiple Sclerosis.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm/Group 2: AZD0120 PMSExperimental Treatment2 Interventions
Group II: Arm/Group 1: AZD0120 RMSExperimental Treatment2 Interventions

Find a Clinic Near You

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

NCT07224373 | An Open-label Study of AZD0120 in Adults ...This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and ...
A Phase Ib/II Study of AZD0120, Dual-Targeting CAR-T ...Phase II aims to evaluate the efficacy of AZD0120, and to further characterize the safety, pharmacodynamic effects, immunogenicity, and changes in health- ...
Innovations in immunotherapy for autoimmune diseasesRelapsing-remitting multiple sclerosis (RRMS) and T1D patients have a considerably low level of LAG-3+ CD4 and CD8 T cells. The low expression ...
New Data: Cell-Depleting Treatment for Severe RMDThe authors report that CAR-T cells and B cell depletion persisted over 24 months, with stable serological remission and major disease improvement.
Multiple Myeloma Clinical TrialsA Study to Evaluate the Safety and Effectiveness of SAR442168 Compared to Placebo in Primary Progressive Multiple Sclerosis (PPMS) Patients Rochester, MN.
An open-label study of AZD0120 in adults with multiple ...Official Title. A Phase 1b, open-label, multi-center, randomized study evaluating the safety and tolerability of AZD0120, an autologous ...
Aiming to reset the immune system to transform immunologyDiscover how AstraZeneca are pioneering cell therapies that have the potential to provide remission in immune-mediated diseases.
Progressive multiple sclerosis: Evaluating current therapies ...In this trial, which enrolled 144 patients across Europe and Canada, MSC therapy was generally safe, with no significant adverse effects ...
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