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CAR-T Cell Therapy in RelApsed/Refractory Myeloma With ExtrameduLlary Disease - an in Vivo Imaging and Molecular Monitoring Study
This clinical trial will investigate the in vivo trafficking of cilta-cel in extramedullary myeloma using 64Cu Super Paramagnetic Iron Oxide Nanoparticle (64Cu SPION) and Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI).
Study details:
This a Phase Ib exploratory study designed to investigate the in vivo trafficking of cilta-cel in extramedullary myeloma (EMM) using 64Cu SPION nanoparticles and PET-MRI imaging. It is planned that 10-30% of clinical dose of target number of cilta-cel will be labelled. The target number cilta-cel has been chosen based on the previous first in humans (FIH) study.
The rationale to label of cilta-cel in the range of ≤30% is to ensure that reasonable positron emission tomography (PET) and magnetic resonance (MR) imaging quality by increasing the relative labelling dose, in the case low cell numbers are obtained. Additionally, the selected range is chosen to limit cellular toxicity and radiation exposure to the patient from the labelled cells. The unlabeled and labelled dose will be administered as scheduled by a two-part intravenous infusion in which the labelled cells are administered no later than 4hrs after the unlabeled infusion.
Eligibility criteria
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Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-12-08
Primary completion: 2026-01-01
Study completion finish: 2027-01-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05666700
Intervention or treatment
BIOLOGICAL: Combination Product: JNJ-68284528 (Cilta-cel) & 64Cu SPION dual PET-MR imaging agent
Conditions
- • Extramedullary Myeloma
Find a site
Closest Location:
Peter MacCallum Cancer Centre
Research sites nearby
Select from list below to view details:
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Cilta-cel
| BIOLOGICAL: Combination Product: JNJ-68284528 (Cilta-cel) & 64Cu SPION dual PET-MR imaging agent
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
To determine the utility of 64Cu SPION labelling for in vivo real time monitoring of trafficking of anti-BCMA Chimeric Antigen Receptor T-Cell (CAR-T) cells in Relapsed/ Refractory (RR) EMM. | Detectable cells by PET assessed by the Deauville score \>3 | assessed up to one month (first month after infusion) |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Safety of 64Cu SPION labelled cilta-cel for EMM | Incidence, nature and severity of adverse events (AEs) according to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) and 2019 American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria for cytokine release syndrome (CRS) and neurotoxicity, Serious Adverse Events (SAE), and Adverse Events of special interest (AESI) | From date of signing consent until study completion, assessed up to approximately 31 months |
Complete response rate (CRR) by International Myeloma Working Group (IMWG) criteria | Using IMWG criteria | assessed up to approximately 13 months |
Overall response rate (ORR) by IMWG criteria | Using IMWG criteria | assessed up to approximately 13 months |
Minimal residual disease response by Adaptive ClonoSeq assay | on ctDNA at Day +1, Day +28, 12 weeks, 24 weeks, and 52 weeks post Day +28 and on Bone Marrow Aspirate (BMA) at Day +28 and at suspected CR | assessed up to approximately 13 months |
Duration of Response by IMWG criteria | Defined as time from first response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR) to time to progressive disease (PD) | assessed up to approximately 13 months |
Progression free survival, defined as time from study enrolment until biochemical, radiological and/or clinical PD or death, according to IMWG criteria | by IMWG criteria | assessed up to approximately 13 months |
Overall survival (OR) | defined as time from study enrolment to death | assessed up to approximately 31 months |
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