A Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

Study Purpose

The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	16 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Key Inclusion Criteria.

- Participants must meet EULAR/ACR 2019 criteria for SLE.

- Participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months.

- Participants must have active disease when signing ICF.

Key

Exclusion Criteria:

- Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE.

- Uncontrolled or clinically significant cardiovascular conditions or CNS pathology participants must not have prior history of malignancies or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years, except for some non-invasive malignancies.

- IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant during participation in the study.

- Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, or stem cell transplant.

Washout periods may be required.

- Participants must not have received live vaccines within 6 weeks before CC-97540 administration.

- Participant must not have inadequate organ function.

- Other protocol defined inclusion/exclusion criteria apply.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07015983
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bristol-Myers Squibb
Principal Investigator Affiliation	Bristol-Myers Squibb
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Portugal, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lupus Erythematosus, Systemic, Lupus Nephritis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Administration of CC-97540

Interventions

Drug: - CC-97540

Specified dose on specified days

Drug: - Fludarabine

Specified dose on specified days

Drug: - Cyclophosphamide

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Local Institution - 0009, Birmingham 4049979, Alabama 4829764

Status

Not yet recruiting

Address

Local Institution - 0009

Birmingham 4049979, Alabama 4829764, 35294-3300

Site Contact

Site 0009

Clinical Trial Finder