RecruitingPhase 1NCT05666700

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


Sponsor

Peter MacCallum Cancer Centre, Australia

Enrollment

10 participants

Start Date

Dec 8, 2023

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates the use of CAR-T cell therapy (a type of personalized immune cell treatment) in people with relapsed or treatment-resistant multiple myeloma (a blood cancer) that has spread outside the bone marrow — a condition called extramedullary disease. The study uses advanced imaging and blood tests to monitor how well the treatment works. **You may be eligible if...** - You are over 18 years old - You have a confirmed diagnosis of multiple myeloma - Your myeloma has spread outside the bone marrow (extramedullary disease) visible on imaging - You have already received at least 2 prior treatment lines, including a proteasome inhibitor and an immunomodulatory drug - You are in good health (ECOG 0–1) - Your life expectancy is at least 3 months - Your blood counts meet the minimum requirements for the procedure - You are able to undergo apheresis (a blood cell collection procedure) **You may NOT be eligible if...** - You have not received at least 2 prior lines of therapy - Your myeloma has not spread outside the bone marrow - Your blood counts or organ function are too low - You are unable to undergo apheresis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCombination 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


Locations(1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

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NCT05666700


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