drugset / Trial / NCT07149857

A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

NCT07149857

Phase 2 Recruiting 60 enrolled Janssen Research & Development, LLC
NaParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate how well (efficacy) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.

Timeline

Start
2025-10-03
Primary completion
2028-04-12
Completion
2029-04-06

Drugs

EvaluationDrugModalityDoseRoute
Subject ciltacabtagene autoleucel Cell therapy Intravenous
Background Bortezomib Small molecule
Background Cyclophosphamide Other / unclassified Intravenous
Background Daratumumab Monoclonal antibody
Background Dexamethasone Small molecule
Background Fludarabine Small molecule Intravenous
Background Lenalidomide Other / unclassified

Indications