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NCT07149857From ClinicalTrials.govRecruiting

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

  • Multiple Myeloma

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Janssen Research & Development, LLC
Enrolment target
60
Started
3 October 2025
Main results due
12 April 2028
Study sites
20
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 80 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria

* 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

Exclusion Criteria

* Frailty index of \>= 2 according to Myeloma Geriatric Assessment score
* Known allergies, hypersensitivity, or intolerance to study intervention or its active agents
* Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib
* Participants who require continuous supplemental oxygen

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(20)

  • University of California San Francisco

    San Francisco, California, United States

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, United States

    Active, not recruiting

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, United States

    Active, not recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, United States

    Active, not recruiting

  • Atrium Health

    Charlotte, North Carolina, United States

    Recruiting

  • Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

    Winston-Salem, North Carolina, United States

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, United States

    Recruiting

  • Royal Prince Alfred Hospital

    Camperdown, Australia

    Recruiting

  • Monash Medical Centre

    Clayton, Australia

    Recruiting

  • Austin Hospital

    Heidelberg, Australia

    Recruiting

  • Fiona Stanley Hospital

    Murdoch, Australia

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Australia

    Recruiting

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, Spain

    Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, Spain

    Recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, Spain

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, Spain

    Recruiting

  • Clinica Univ. de Navarra

    Pamplona, Spain

    Recruiting

  • Hosp Clinico Univ de Salamanca

    Salamanca, Spain

    Recruiting

  • Hosp. Univ. Marques de Valdecilla

    Santander, Spain

    Recruiting

  • Hosp. Virgen Del Rocio

    Seville, Spain

    Recruiting

Showing 20 of 20 sites. 17 of the 20 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07149857. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel | Trialion