Health Trials

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

ConditionsSystemic Lupus ErythematosusIdiopathic Inflammatory MyopathySystemic SclerosisRheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company

About this trial

The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).

Eligibility criteria

Qualifiers

Diagnosis of Idiopathic Inflammatory Myopathy (IIM) defined as follows:.

IIM disease activity:.

Diagnosis of Systemic Sclerosis (SSc) defined as follows:.

Disqualifiers

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:.

Trial design

Treatments tested in this trial

  • CC-97540
  • Fludarabine
  • Cyclophosphamide
  • Tocilizumab

Treatment groups

270 Participants
are divided into 1 treatment group

Sponsors and collaborators

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

Lead sponsor

Bristol-Myers Squibb Services Unlimited Company

Collaborator

Source ClinicalTrials.gov