Clinical Trials in Australia / NCT06550895
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
Condition(s) studied
Multiple Myeloma
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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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