Not yet recruitingPHASE2INTERVENTIONAL

Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE)

This study is for adults with two specific blood conditions: chronic immune thrombocytopenia (ITP) or autoimmune hemolytic anemia (AIHA). These conditions happen when your body's immune system mistakenly attacks its own blood cells. The researchers are testing a new investigational medicine called Zola-cel (BMS-986353) to see if it's safe and effective. Participants will also receive standard treatments like Fludarabine Phosphate and Cyclophosphamide. The main aim is to find out if this new treatment can help people who haven't responded well to other therapies. This is a Phase 2 study, meaning it's still in the earlier stages of research.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Enrolment target

Start

15 Jun 2026

Estimated completion

06 May 2030

Chronic Immune Thrombocytopenia Autoimmune Hemolytic Anemia

What is this study about?

This research study, called Breakfree-AiCE, is investigating a new medication, Zola-cel (also known as BMS-986353), for adults living with two specific types of blood disorders: chronic immune thrombocytopenia (cITP) and autoimmune hemolytic anemia (AIHA). In both conditions, the body's immune system, which normally fights off infections, mistakenly attacks and destroys its own blood cells. In cITP, it attacks platelets (tiny cells that help blood clot), leading to easy bruising and bleeding. In AIHA, it attacks red blood cells, causing anemia, which can make you feel tired and weak.

The main purpose of this study is to check how safe this new medicine is and how well it works for people who have these conditions and haven't found enough relief from other treatments. The study aims to see if Zola-cel can help to improve the number of blood cells in people with cITP and AIHA. This is really important because it could offer a new option for managing these challenging conditions.

This is a Phase 2 clinical trial, which means it's an earlier stage of research where doctors are carefully studying the treatment in a small group of people to determine its safety and effectiveness before potentially moving on to larger studies. Some participants will also receive other standard medications like Fludarabine Phosphate and Cyclophosphamide as part of their treatment.

Key takeaways

The study is for adults with specific blood conditions: chronic ITP or AIHA.
It's testing a new medicine called Zola-cel (BMS-986353).
It's for people who haven't responded well to other treatments.
The goal is to check safety and how well the new medicine works.
Participants may also receive other standard medications.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 18 and over, of any gender. People with chronic immune thrombocytopenia (cITP) might be able to join if they've already tried and not responded well to, or couldn't tolerate, steroid treatments (with or without other immune-boosting medicines) AND at least two other types of treatments that work in different ways to control the condition. Also, your platelet count needs to be quite low, usually below 30. If you're on a certain medication that helps your body make more platelets, your count needs to be below 50.

If you have autoimmune hemolytic anemia (AIHA), you might be able to join if you've already tried and not responded well to, or couldn't tolerate, at least two different types of treatments, and for some types of AIHA, one of these treatments needs to be a specific kind of medicine called an anti-CD20 antibody. Your red blood cell levels also need to be low (below 10), or you need regular blood transfusions because your body is destroying too many red blood cells.

There are also some reasons why you might not be able to take part. For example, if your ITP or AIHA is linked to other specific conditions like hepatitis C, HIV, certain cancers, or if it's caused by a medication you're taking. If you've recently had a specific type of vaccine-related clotting disorder, you also wouldn't be able to join.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of chronic ITP or AIHA (warm AIHA, cold agglutinin disease, or mixed AIHA)?
Have you tried and not responded well to or tolerated previous treatments for your condition?
Is your platelet count (for ITP) or red blood cell level (for AIHA) currently low?
Is your ITP or AIHA NOT caused by another specific underlying condition (like hepatitis C, HIV, or certain cancers)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will likely have a number of visits to the study clinic for check-ups, blood tests, and to receive the study medication. These visits will allow the doctors to monitor your health, check how you're responding to the treatment, and look for any side effects. You'll receive the investigational medicine Zola-cel, and potentially other standard treatments like Fludarabine Phosphate and Cyclophosphamide. The total duration of your participation in the study will depend on the phase of treatment and follow-up required, which will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment that isn't widely available and close medical monitoring. However, there are also potential risks, as the new medicine's full effects are still being studied. You might experience side effects, or the treatment might not work for you. All potential risks and side effects will be explained in detail by the study team. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

Local Institution - 101
Boston, United States
Local Institution - 103
Houston, United States
Local Institution - 102
Seattle, United States
Local Institution - 201
Odense, Denmark
Local Institution - 301
Magdeburg, Germany
Local Institution - 302
Erlangen, Germany
Local Institution - 401
London, United Kingdom
Local Institution - 402
Sheffield, United Kingdom

Common questions

What are chronic ITP and AIHA?

These are conditions where your body's immune system mistakenly attacks and destroys its own blood cells – platelets in ITP and red blood cells in AIHA.

What is Zola-cel (BMS-986353)?

Zola-cel is a new investigational medicine being tested in this study to see if it can help people with chronic ITP and AIHA.

Why is this study important?

This study aims to find a new treatment option for people with chronic ITP and AIHA who haven't responded well to current therapies.

How long will I be in the study?

The exact length of time you'd be in the study will be explained by the study team, as it varies depending on the treatment and follow-up needed.

Will I receive other medicines during the study?

Yes, some participants will also receive other standard treatments like Fludarabine Phosphate and Cyclophosphamide as part of the study.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Clinical.Trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.