A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
- Conditions
- Systemic SclerosisSystemic Lupus ErythematosusIdiopathic 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Administration of CC-97540 CC-97540 - Administration of CC-97540 Cyclophosphamide - Administration of CC-97540 Tocilizumab - Administration of CC-97540 Fludarabine -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Response At 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) remission At 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
Scroll for more (43 remaining)University of Colorado Anschutz Medical Campus🇺🇸Aurora, Colorado, United StatesMelissa Griffith, Site 0035Contact720-848-7700