A Phase 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants (Breakfree-SLE)

ReclutandoFase 2ClinicalTrials.gov

ID: NCT07015983Tipo: INTERVENTIONALInicio: 14 de jul de 2025Fin estimado: 15 de jun de 2032

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 16 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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, stem cell transplant or organ transplant.
Participants must not have received live vaccines within 6 weeks before LDC (lymphodepleting chemotherapy) administration.
Participant must not have inadequate organ function.

Intervenciones

drug

CC-97540

Specified dose on specified days

drug

Fludarabine

Specified dose on specified days

drug

Cyclophosphamide

Specified dose on specified days

Ubicaciones

Local Institution - 0016

ABB, Buenos Aires F.D., Argentina

Site 0016

NOT_YET_RECRUITING

Local Institution - 0017

ABB, Buenos Aires F.D., Argentina

WITHDRAWN

Local Institution - 0023

Buenos Aires, Buenos Aires F.D., Argentina

Site 0023

NOT_YET_RECRUITING

Local Institution - 0077

Córdoba, Argentina

Site 0077

NOT_YET_RECRUITING

Patrocinadores

PrincipalJuno Therapeutics, Inc., a Bristol-Myers Squibb Company

Contactos

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

Clinical.Trials@bms.com 855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

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