A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

Part of paid clinical trials in San Francisco, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07149857
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cilta-cel — DRUG
    Cilta-cel will be administered as intravenous infusion.
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be administered as intravenous infusion.
  • Induction therapy — DRUG
    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 — DRUG
    Fludarabine will be administered as intravenous infusion.

Study Details

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.

Key Dates

Start date
Oct 3, 2025
Status verified
Jun 2026
Primary completion
Apr 12, 2028
Completion
Apr 6, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Participants will undergo apheresis and continue to receive 1-2 more cycles of the induction regimen (DRd, VRd or DVRd regimen, in accordance with institution standard of care, and is not considered study treatment) that they were receiving prior to screening. After completion of induction therapy, participants will receive a conditioning regimen of cyclophosphamide daily for 3 days, followed by cilta-cel IV infusion on Day 1. Participants will later enter the post-treatment phase, which will start on Day 113 and last until end of study or cohort completion.
  • Experimental: Cohort B
    Participants will undergo apheresis and continue to receive 1-2 more cycles of the induction regimen (DRd, VRd or DVRd regimen, in accordance with institution standard of care, and is not considered study treatment) that they were receiving prior to screening. After completion of induction therapy, participants will receive a conditioning regimen of cyclophosphamide and fludarabine daily for 3 days, followed by Ciltacel IV infusion on Day 1. Participants will later enter the post-treatment phase, which will start on Day 113 and last until end of study or cohort completion.

Primary Outcome Measure

Minimal Residual Disease (MRD)-negative Complete Response (CR) After Cilta-cel Infusion [ Time Frame: At least 12 months after Cilta-cel infusion on Day 1 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143-
Moffitt Cancer CenterTampaFlorida33612-
University of Iowa Hospital and ClinicsIowa CityIowa52242-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Cleveland ClinicClevelandOhio44195-

Find similar trials in San Francisco, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of California San Francisco· San Francisco, CAMoffitt Cancer Center· Tampa, FLUniversity of Iowa Hospital and Clinics· Iowa City, IAMemorial Sloan Kettering Cancer Center· New York, NYCleveland Clinic· Cleveland, OH

Related Studies