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A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel
Sponsor: Janssen Research & Development, LLC
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.
Official title: A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-10-03
Completion Date
2029-04-06
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Cilta-cel
Cilta-cel will be administered as intravenous infusion.
Cyclophosphamide
Cyclophosphamide will be administered as intravenous infusion.
Induction therapy
Induction therapy consist of bortezomib, lenalidomide, and dexamethasone (VRd) or daratumumab, lenalidomide, and dexamethasone (DRd) or daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd), will will be administered.
Fludarabine
Fludarabine will be administered as intravenous infusion.
Locations (15)
Moffitt Cancer Center
Tampa, Florida, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Royal Prince Alfred Hospital
Camperdown, Australia
Austin Hospital
Heidelberg, Australia
Fiona Stanley Hospital
Murdoch, Australia
Princess Alexandra Hospital
Woolloongabba, Australia
Hosp. Univ. Germans Trias I Pujol
Badalona, Spain
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp. Clinic de Barcelona
Barcelona, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
Clinica Univ. de Navarra
Pamplona, Spain
Hosp Clinico Univ de Salamanca
Salamanca, Spain
Hosp. Univ. Marques de Valdecilla
Santander, Spain
Hosp. Virgen Del Rocio
Seville, Spain