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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