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: Drug: CC-97540; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Tocilizumab

• 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

Study Timeline

• Study First Submitted: 2023-05-11
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-05-23
• Study Start: 2023-09-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Primary Completion: 2028-08-29
• Study Completion: 2028-08-29

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

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
Change in Health Assessment Questionnaire - Disability Index (HAQ-DI)	At week 24
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
Time of maximum observed blood concentration (Tmax)	Up to 2 years
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)

Hôpital Saint-Louis; 🇫🇷 Paris, France

Local Institution - 0052; 🇫🇷 Paris, France

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou; 🇫🇷 Rennes, France

Universitaetsklinikum Wuerzburg; 🇩🇪 Wuerzburg, Bayern, Germany

CHU Montpellier Lapeyronie Hospital; 🇫🇷 Montpellier, Hérault, France

Hopital Claude Huriez - CHU de Lille; 🇫🇷 Lille, France

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet; 🇫🇷 Nice, France

Local Institution - 0054; 🇺🇸 New York, New York, United States

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

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Henry Ford Medical Center - New Center One; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic in Rochester, Minnesota; 🇺🇸 Rochester, Minnesota, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

University Of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Atlantic Health System Overlook Medical Center; 🇺🇸 Summit, New Jersey, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

Local Institution - 0055; 🇺🇸 New York, New York, United States

The University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Local Institution - 0027; 🇺🇸 Columbus, Ohio, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

Local Institution - 0057; 🇺🇸 Seattle, Washington, United States

Fred Hutchinson Cancer Center; 🇺🇸 Seattle, Washington, United States

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium

Local Institution - 0043; 🇫🇷 Strasbourg, Alsace, France

CHU Bordeaux Haut-Leveque; 🇫🇷 Pessac, Aquitaine, France

Universitaetsklinikum Koeln; 🇩🇪 Köln, Nordrhein-Westfalen, Germany

Local Institution - 0045; 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Sachsen, Germany

Charité Universitaetsmedizin Berlin - Campus Mitte; 🇩🇪 Berlin, Germany

Universitaetsklinikum Duesseldorf; 🇩🇪 Düsseldorf, Germany

Universitaetsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore; 🇮🇹 Roma, Lazio, Italy

Humanitas; 🇮🇹 Rozzano, Milano, Italy

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Barcelona [Barcelona], Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Catalunya [Cataluña], Spain

Hospital Universitario Reina Sofia; 🇪🇸 Cordoba, Spain

H.R.U Málaga - Hospital General; 🇪🇸 Málaga, Spain