CD19-Targeted NEX-T CAR T

DRUG4 trials

Sponsors

Celgene Corp.

Conditions

Chronic Immune Thrombocytopenia (cITP) and Autoimmune Hemolytic Anemia (AIHA)Defined by parent protocol. The study will enroll all adult and paediatric subjects who received at least one genetically modified T cells infusion in a previous Celgene sponsored study.Lupus NephritisSystemic Lupus ErythematosusSystemic Sclerosis

Phase 2

LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH GENE-MODIFIED T CELLS

RecruitingCTIS2023-504201-36-00

Celgene Corp.Defined by parent protocol. The study will enroll all adult and paediatric subjects who received at least one genetically modified T cells infusion in a previous Celgene sponsored study.

Start: 2018-12-21Target: 214Updated: 2025-10-27

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)

RecruitingCTIS2024-519278-37-00

Celgene Corp.Systemic Lupus Erythematosus, Lupus Nephritis

Start: 2025-10-22Target: 35Updated: 2025-12-03

A Phase 2, Multicenter, Open-Label Study of Zolacabtagene Autoleucel (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants with Chronic Immune Thrombocytopenia (cITP) and Autoimmune Hemolytic Anemia (AIHA) (Breakfree-AiCE)

Not yet recruitingCTIS2025-524993-41-00

Celgene Corp.Chronic Immune Thrombocytopenia (cITP) and Autoimmune Hemolytic Anemia (AIHA)

Target: 1Updated: 2026-08-10

Phase 3

A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants with Active Systemic Sclerosis (Breakfree-SSc)

Not yet recruitingCTIS2025-524337-11-00

Celgene Corp.Systemic Sclerosis

Target: 33Updated: 2026-06-22