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

Running, not enrolling · Phase 2

Conditions studied: Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT06550895

Run by

Janssen Research & Development, LLC

People needed

11

Starts

2024-09-16

Expected to finish

2027-08-26

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Royal Prince Alfred Hospital — Camperdown, Australia
• Austin Hospital — Heidelberg, Australia
• Peter MacCallum Cancer Centre — Melbourne, Australia
• The Alfred Hospital — Melbourne, Australia

Full record on ClinicalTrials.gov

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