drugset
drugset / Trial / NCT07015983

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

NCT07015983 ↗

Phase 2 Recruiting 89 enrolled Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-07-14
Primary completion
2028-05-17
Completion
2032-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Zolacabtagene- Autoleucel Cell therapy — —
Background Cyclophosphamide Other / unclassified — —
Background Fludarabine Small molecule — —

Indications

lupus nephritis systemic lupus erythematosus