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

Recruiting Phase 1 Interventional Study
Systemic Lupus Erythematosus Idiopathic Inflammatory Myopathy Systemic Sclerosis Rheumatoid Arthritis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
270 (estimated)
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Industry
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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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria \- Diagnosis of Systemic Lupus Erythematosus (SLE) defined as follows:. i) Fulfilling the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria of SLE. ii) Presence of anti-dsDNA, anti-histone, anti-chromatin, anti-Ro (…
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