Status:
ACTIVE_NOT_RECRUITING
A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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).
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Stroke, transient ischemic attack, or seizure within 6 months of signing informed consent form
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2026
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06550895
Start Date
September 16 2024
End Date
November 30 2026
Last Update
December 5 2025
Active Locations (9)
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1
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
2
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
3
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029