Ireland
--:--IST
Active, not recruiting Phase 2

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

NCT06550895 · tracked via the Priya Life Science Australia tracker
Phase
Phase 2
Started
2024-09-16
Last updated
2026-11-03

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Cilta-cel →Talquetamab →

Cilta-cel: Cilta-cel infusion will be administered intravenously.

Talquetamab: Talquetamab will be administered subcutaneously.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

  • Number of Participants With Adverse Events (AE) by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 — Up to 3 years and 5 months
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product. The severity of AEs has 5 grades based on NCI-CTCAE version 5.0 criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death.

Trial sites (9)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06550895 on ClinicalTrials.gov ↗ ← All trials in Australia