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Study of CC-97540 for Severe Autoimmune Diseases

This study, called Breakfree-1, is looking at a new cell therapy called CC-97540 for people with severe autoimmune diseases like Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy, Systemic Sclerosis, or Rheumatoid Arthritis. These are conditions where your body's immune system mistakenly attacks healthy tissues. The study wants to see how safe CC-97540 is and if it helps improve these conditions. Participants will receive CC-97540 along with other medications like Fludarabine, Cyclophosphamide, and Tocilizumab. Researchers will track side effects for up to two years after treatment. To join, you must be at least 18 years old and have a specific diagnosis of SLE with certain antibodies present. The study plans to enroll 270 people, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 270 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years after receiving CC-97540 infusion to monitor for adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05869955

A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
~270 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:CC-97540FludarabineCyclophosphamideTocilizumab

At a glance

Recruiting sites
0 of 46 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-emergent adverse events (AEs) in each indication.
Measured over Up to 2 years after CC-97540 infusion
+5 more outcomes measured

Conditions

Systemic Lupus Erythematosus
Idiopathic Inflammatory Myopathy
Systemic Sclerosis
Rheumatoid Arthritis

Explore related trials

Idiopathic Inflammatory MyopathyRheumatoid ArthritisSystemic Lupus ErythematosusSystemic Scleroderma

Where it's being run

46 sites across 29 states
France4
Massachusetts3
New York3
Texas3
Washington3
Germany3
Colorado2
Florida2

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of Idiopathic Inflammatory Myopathy (IIM) defined as follows:.
IIM disease activity:.
Diagnosis of Systemic Sclerosis (SSc) defined as follows:.

Exclusion

SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease, are excluded.
Present or recent clinically significant CNS pathology, within 12 months.
IIM disease activity:.

What this trial measures

  • Number of participants with treatment-emergent adverse events (AEs) in each indication.Up to 2 years after CC-97540 infusion
  • Number of participants with serious AEs (SAEs) in each indication.Up to 2 years after CC-97540 infusion
  • Number of participants with AEs of special interest (AESI) in each indication.Up to 2 years after CC-97540 infusion
  • Number of participants with laboratory abnormalities in each indication.Up to 2 years after CC-97540 infusion
  • Number of participants with Dose Limiting Toxicities (DLT) in each indication.Up to 2 years after CC-97540 infusion
  • Recommended Phase 2 Dose (RP2D) of CC-97540 in each indication.Up to 2 years after CC-97540 infusion