RecruitingPHASE2INTERVENTIONAL

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

This research is looking into a new treatment called CC-97540, also known as Zola-cel. It's a special type of cell therapy designed to target certain cells in the body. The study focuses on people who have systemic lupus erythematosus (SLE), which is an autoimmune disease, including those who also have lupus affecting their kidneys (lupus nephritis). We want to find out how well CC-97540 works, how safe it is, and what levels of the treatment are in the body. This study is for people whose lupus is still active despite having already tried certain steroid medications and at least two other types of immune-suppressing drugs.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

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

Enrolment target

Start

14 Jul 2025

Estimated completion

15 Jun 2032

Lupus Erythematosus, Systemic Lupus Nephritis

What is this study about?

This study is investigating a new treatment called CC-97540 (you might also hear it called Zola-cel). It's a type of advanced therapy known as CAR T-cell therapy. In simple terms, this treatment involves taking some of your own immune cells, called T-cells, and specially training them in a lab to find and fight certain other cells that are causing problems in lupus. Once these 'trained' T-cells are ready, they are given back to you.

The main goal of this research is to see if CC-97540 can help people with systemic lupus erythematosus (SLE), which is a long-term condition where the body's immune system mistakenly attacks healthy tissues. This study specifically includes people who also have lupus affecting their kidneys, known as lupus nephritis. We want to understand if this new treatment can make a difference for people whose lupus is still active even though they've already tried usual treatments like steroid medicines and at least two other types of strong immune-suppressing drugs.

This is a 'Phase 2' study, which means we're looking carefully at how safe the treatment is and how well it works. It's an important step in developing new medicines, particularly for conditions like lupus where current treatments don't always work for everyone. We'll be checking how effective the treatment is, monitoring for any side effects, and measuring the amount of the treatment in your body.

Key takeaways

This study is testing a new cell therapy (CC-97540) for active lupus.
It's for people whose lupus hasn't responded well to standard treatments.
The study examines both the safety and effectiveness of the new therapy.
It aims to see if CC-97540 can be a new option for severe lupus, including kidney involvement.
Participation involves monitoring, cell collection, and receiving the treatment.

Who may be eligible?

To join this study, you need to have a diagnosis of systemic lupus erythematosus (SLE) that continues to be active, even after taking steroid medications and at least two other medicines that calm your immune system for at least three months. You must be at least 16 years old.

There are also some reasons why you might not be able to join. For example, if you have other serious health conditions that might make it difficult to tell if the treatment is working, or if you have certain heart problems or brain conditions. You also can't have had cancer or certain immune system cancers in the last two years (some very minor or non-spreading skin cancers might be an exception).

Additionally, you cannot take part if you are pregnant, breastfeeding, or planning to become pregnant. If you've previously had CAR T-cell therapy, other similar cell therapies, or an organ transplant, you wouldn't be able to join. You also can't have received certain 'live' vaccines in the six weeks before starting the study treatment, and your organs need to be working well enough to safely receive the treatment.

Quick self-check

Do I have active lupus (SLE) that meets specific criteria?
Has my lupus failed to improve with steroid medicine and at least two other immune-suppressing drugs?
Am I at least 16 years old?
Am I not currently pregnant or breastfeeding, and not planning to become pregnant?
Have I not had previous CAR T-cell therapy or an organ transplant?

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

What does participation involve?

If you decide to join this study, you'll first have a period of screening tests to make sure you meet all the requirements. If you do, you'll undergo a procedure to collect your own immune cells for the special CC-97540 treatment. Before receiving the CC-97540, you'll have some short-term chemotherapy (medicine to lower your immune system) called fludarabine and cyclophosphamide. This helps prepare your body for the new cells. Then, you'll receive the CC-97540 treatment.

During the study, you'll have regular visits to the clinic for assessments, including blood tests, physical exams, and possibly other scans or tests to check your lupus activity, how well the treatment is working, and to monitor for any side effects. The number and frequency of visits will be explained in detail by the study team. You'll also have follow-up visits for a longer period to ensure your safety and monitor the long-term effects of the treatment. The total duration of your involvement in the study, including follow-up, will be made clear by the research team.

Potential risks and benefits

Participating in this study might offer a potential benefit if CC-97540 helps to control your lupus when other treatments haven't worked well. However, it's important to remember that this is a new treatment, and there are potential risks, including side effects from the chemotherapy and the cell therapy itself. These risks will be explained in detail by the study team. Your health and safety are the top priority, and you will be closely monitored throughout the study. Remember, joining is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (95)

Local Institution - 0106
Scottsdale, United States· Not yet recruiting
Local Institution - 0038
Los Angeles, United States· Not yet recruiting
Local Institution - 0051
Los Angeles, United States· Not yet recruiting
Local Institution - 0093
Newport Beach, United States· Not yet recruiting
Lucile Packard Children's Hospital
Palo Alto, United States· Recruiting
University of Colorado Anschutz Medical Campus
Aurora, United States· Recruiting
Local Institution - 0105
Denver, United States· Not yet recruiting
Mayo Clinic in Florida
Jacksonville, United States· Recruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, United States· Recruiting
Local Institution - 0073
Orlando, United States· Not yet recruiting
Moffitt Cancer Center
Tampa, United States· Recruiting
USF Health
Tampa, United States· Recruiting

+83 more sites — see the official record for the full list.

Common questions

What is systemic lupus erythematosus (SLE)?

SLE is a long-term condition where your body's immune system mistakenly attacks healthy tissues, causing inflammation and damage in various parts of the body.

What is lupus nephritis?

This is when lupus specifically affects your kidneys, which can cause them to not work as well as they should.

What is CC-97540?

It's a special type of cell therapy that uses your own immune cells, trained in a lab to target and fight cells causing problems in lupus.

Why is this study only for people whose lupus is still active?

This study focuses on people for whom standard treatments haven't been enough, to see if this new therapy can offer a new option for very active lupus.

Are there any other treatments given in the study?

Yes, before receiving the main treatment, you'll have a short course of chemotherapy called fludarabine and cyclophosphamide to prepare your body.

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.