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NCT06550895Active, not recruitingPhase 2

A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to define the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in participants with high-risk multiple myeloma (MM).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
11 (actual)
First submitted
9 Aug 2024
Start date
16 Sept 2024
Primary completion date
26 Aug 2027
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT06550895
EU CT number
2023-507989-76-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 11
  • From 16 Sept 2024 to the primary completion date, 26 Aug 2027
  • 9 sites in 2 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

  • Cohort 1: Prior treatment with chimeric antigen receptor T cell (CAR-T) therapy directed at any target or any prior B cell maturation antigen (BCMA)-directed therapy/prior G protein-coupled receptor family C Group 5 member D (GPRC5D)-directed therapy
  • Cohort 1: Received either of the following: An allogenic stem cell transplant within 6 months before apheresis/first dose of study drug and no immunosuppressive medications administered before the start of study treatment. And secondly, received an autologous stem cell transplant less than (\<)12 weeks before apheresis/first dose of study treatment
  • Receive live, attenuated vaccine within 4 weeks of enrollment
  • Toxicity from previous anticancer therapy not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy

Other illness

  • Stroke, transient ischemic attack, or seizure within 6 months of signing informed consent form

Who the study is looking for

  • Documented diagnosis of MM according to the IMWG diagnostic criteria and is defined as a measurable disease at screening
  • Cohort 1: Received at least 3 prior lines of antimyeloma therapy and have undergone greater than or equal to (\>=) 1 complete cycle of the therapy
  • Cohort 1: Documented evidence of progression of disease (PD) or failure to achieve a response to the last line of therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Participant of childbearing potential (POCBP) must have a negative pregnancy test using a highly sensitive β-human chorionic gonadotropin (hCG) serum pregnancy test at screening

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

Full criteria on ClinicalTrials.gov

Sites (9)

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
CamperdownAustraliaUnknown status
Austin Hospital
Coordinator of this site? Confirm its status
HeidelbergAustraliaUnknown status
Peter MacCallum Cancer Centre
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
The Alfred Hospital
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Barbara Ann Karmanos Cancer Institute
Coordinator of this site? Confirm its status
DetroitUnited StatesUnknown status
University of Iowa Hospital and Clinics
Coordinator of this site? Confirm its status
Iowa CityUnited StatesUnknown status
Norton Cancer Institute
Coordinator of this site? Confirm its status
LouisvilleUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status

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