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

ConditionsSystemic Lupus Erythematosus Idiopathic Inflammatory Myopathy Systemic Sclerosis Rheumatoid 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

Locations

Belgium

UZ Leuven3000, LeuvenVlaams-Brabant, Belgium

France

Local Institution - 004367098, StrasbourgAlsace, France

CHU Bordeaux Haut-Leveque33600, PessacAquitaine, France

CHU Montpellier Lapeyronie Hospital34295, MontpellierHérault, France

Sponsors and collaborators

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

Lead sponsor

Bristol-Myers Squibb Services Unlimited Company

Collaborator

Source ClinicalTrials.gov