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RECRUITING
NCT07149857
PHASE2

A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

Cilta-cel

Cilta-cel will be administered as intravenous infusion.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered as intravenous infusion.

DRUG

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.

DRUG

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