NCT05666700

CAR-T Cell Therapy in RelApsed/Refractory Myeloma With ExtrameduLlary Disease - an in Vivo Imaging and Molecular Monitoring Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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

Conditions

• Extramedullary Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Combination Product: JNJ-68284528 (Cilta-cel) & 64Cu SPION dual PET-MR imaging agent	Cilta-cel is a cellular immunotherapy derived from autologous CD3+ T-cells that have undergone ex vivo modification to target B-Cell Maturation Antigen (BCMA) on the surface of plasma cells. Cilta-cel will be administered as two IV infusions, ≥70% unlabeled and ≤30% labelled. The dose will be based on the patient's weight (kg) at apheresis

Timeline

• Start date: 2023-12-08
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2022-12-28
• Last updated: 2024-04-11

Locations

1 site across 1 country: Australia