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NCT07149857RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
25 Aug 2025
Start date
3 Oct 2025
Primary completion date
12 Apr 2028
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT07149857
EU CT number
2025-521975-30-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 60
  • From 3 Oct 2025 to the primary completion date, 12 Apr 2028
  • 20 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib

Other illness

  • Known allergies, hypersensitivity, or intolerance to study intervention or its active agents

Other

  • Frailty index of \>= 2 according to Myeloma Geriatric Assessment score
  • Participants who require continuous supplemental oxygen

Who the study is looking for

  • Documented diagnosis of newly diagnosed multiple myeloma (NDMM) according to the most recent international myeloma working group (IMWG) diagnostic criteria and measurable disease at diagnosis (prior to start of any anti-myeloma therapy): Serum monoclonal paraprotein (M-protein) level greater than equal to (\>=)1.0 grams per deciliter (g/dL) or urine M-protein level \>= 200 milligrams (mg)/24 hours; or light chain multiple myeloma in whom the only measurable disease is by serum free light chain (FLC) levels in the serum: involved serum free light chain \>= 10 mg/dL and abnormal serum free light chain ratio
  • Not considered a candidate for high-dose chemotherapy with stem cell transplantation due to: (a) Advanced age; or (b) Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with stem cell transplantation; or (c) Participant refusal of high-dose chemotherapy with stem cell transplantation as initial treatment
  • Participant must have received at least 3 cycles and no more than 5 cycles of induction therapy. Initially, only participants receiving triplet induction therapy with DRd or VRd will be enrolled. Only after sponsor notification, participants receiving quadruplet DVRd induction therapy may be enrolled (screening can commence as early as during Cycle 3 of induction). Participants must have achieved \>= partial response (PR) on the most recent disease assessment to be enrolled
  • Eastern cooperative oncology group (ECOG) Performance Status score of 0 or 1
  • Must be willing and able to adhere to the lifestyle restrictions specified in the protocol

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Prince Alfred Hospital
Coordinator of this site? Confirm its status
CamperdownAustraliaRecruiting
Monash Medical Centre
Coordinator of this site? Confirm its status
ClaytonAustraliaRecruiting
Austin Hospital
Coordinator of this site? Confirm its status
HeidelbergAustraliaRecruiting
Fiona Stanley Hospital
Coordinator of this site? Confirm its status
MurdochAustraliaRecruiting
Princess Alexandra Hospital
Coordinator of this site? Confirm its status
WoolloongabbaAustraliaRecruiting
Hospital Germans Trias i Pujol
Coordinator of this site? Confirm its status
BadalonaSpainRecruiting
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Clínica Universidad de navarra
Coordinator of this site? Confirm its status
PamplonaSpainRecruiting
Hospital Universitario De Salamanca
Coordinator of this site? Confirm its status
SalamancaSpainRecruiting
Hospital Universitario Marqués de Valdecilla
Coordinator of this site? Confirm its status
SantanderSpainRecruiting
University Hospital Virgen Del Rocio S.L.
Coordinator of this site? Confirm its status
SevillaSpainRecruiting
Atrium Health
Coordinator of this site? Confirm its status
CharlotteUnited StatesActive, not recruiting
Cleveland Clinic
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ClevelandUnited StatesRecruiting
University of Iowa Hospital and Clinics
Coordinator of this site? Confirm its status
Iowa CityUnited StatesActive, not recruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesActive, not recruiting
University of California San Francisco
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San FranciscoUnited StatesRecruiting
Moffitt Cancer Center
Coordinator of this site? Confirm its status
TampaUnited StatesActive, not recruiting
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.