NCT07149857

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-03
• Primary completion: 2028-04-12
• Completion: 2029-04-06
• First posted: 2025-09-02
• Last updated: 2026-04-13

Locations

16 sites across 3 countries: United States, Australia, Spain

Regulatory

• FDA-regulated drug study