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

Phase 1
Recruiting
Conditions
Systemic Sclerosis
Systemic Lupus Erythematosus
Idiopathic Inflammatory Myopathy
Interventions
Registration Number
NCT05869955
Lead Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Brief Summary

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).

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
144
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Administration of CC-97540CC-97540-
Administration of CC-97540Cyclophosphamide-
Administration of CC-97540Tocilizumab-
Administration of CC-97540Fludarabine-
Primary Outcome Measures
NameTimeMethod
Number of participants with treatment-emergent adverse events (AEs) 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 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
Number of participants with laboratory abnormalities 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
Secondary Outcome Measures
NameTimeMethod
Time of maximum observed blood concentration (Tmax)Up to 2 years
Change in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)At Week 24

Only Dermatomyositis (DM) participants in the IIM Cohort

Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)At week 24

SLE Cohort

Change in proteinuria measured by urine protein creatinine ratio (UPCR)At week 24

SLE Cohort

Proportion of participants achieving Myositis Response Criteria (MRC) Total Improvement Score (TIS) Major ResponseAt Week 24

IIM Cohort

Proportion of participants with ILD with no worsening of pulmonary function including forced expiratory volume (FEV1) (> 10%), forced vital capacity (FVC) (> 10%), and diffusing capacity of the lung for carbon monoxide (DLCO) (> 15%)At Week 24

IIM Cohort

The worsening of pulmonary function including FVC (>10% absolute), DLCO (>15% absolute decline) in participants with interstitial lung disease (ILD)At Week 24

SSc Cohort

Participants with an improvement from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS)At Week 24

SSc Cohort

Maximum observed blood concentration (Cmax)Up to 2 years
Proportion of participants achieving definition of remission in SLE (DORIS) remissionAt week 24

SLE Cohort

Change in Health Assessment Questionnaire - Disability Index (HAQ-DI)At week 24
Proportion of participants achieving a minimal clinically important difference (MCID) of 24% change from baseline of the modified Rodnan Skin Score (mRSS)At Week 24

SSc Cohort

Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))Up to 2 years

Trial Locations

Locations (53)

University of Colorado Anschutz Medical Campus

🇺🇸

Aurora, Colorado, United States

Colorado Blood Cancer Institute

🇺🇸

Denver, Colorado, United States

Local Institution - 0048

🇺🇸

New Haven, Connecticut, United States

Mayo Clinic in Florida

🇺🇸

Jacksonville, Florida, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center

🇺🇸

Miami, Florida, United States

Local Institution - 0053

🇺🇸

Chicago, Illinois, United States

Local Institution - 0030

🇺🇸

Baltimore, Maryland, United States

Local Institution - 0038

🇺🇸

Boston, Massachusetts, United States

Local Institution - 0046

🇺🇸

Boston, Massachusetts, United States

University of Massachusetts Chan Medical School

🇺🇸

Worcester, Massachusetts, United States

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University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Melissa Griffith, Site 0035
Contact
720-848-7700

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