RecruitingPhase 2NCT07149857

A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel


Sponsor

Janssen Research & Development, LLC

Enrollment

60 participants

Start Date

Oct 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR T-cell therapy called ciltacabtagene autoleucel (cilta-cel) in people with newly diagnosed multiple myeloma who are not candidates for high-dose chemotherapy with a stem cell transplant. Multiple myeloma is a blood cancer affecting plasma cells in the bone marrow. **You may be eligible if...** - You have been newly diagnosed with multiple myeloma - Your disease is measurable by specific blood or urine protein markers - You are not eligible for high-dose chemotherapy with stem cell transplant due to age or other health conditions **You may NOT be eligible if...** - You have already received substantial prior treatment for multiple myeloma - You have significant organ dysfunction that makes this therapy unsafe - You have conditions that exclude you from CAR T-cell therapy (such as active serious infection) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCilta-cel

Cilta-cel will be administered as intravenous infusion.

DRUGCyclophosphamide

Cyclophosphamide will be administered as intravenous infusion.

DRUGInduction 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.

DRUGFludarabine

Fludarabine will be administered as intravenous infusion.


Locations(16)

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

Cleveland Clinic

Cleveland, Ohio, 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

View Full Details on ClinicalTrials.gov

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NCT07149857


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