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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeter MacCallum Cancer Centre, Australia

About this trial

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 criteria

Qualifiers

Patient has provided written informed consent

Patient is >18 years of age at the time of consent

Patient has a documented diagnosis of MM according to the IMWG diagnostic criteria (Appendix 1)

Measurable extramedullary disease by any imaging modality (at least one site of disease ≥1cm that has never received radiotherapy or has progressed following radiotherapy). Presence of biochemical measurable disease is not required

Disqualifiers

Known nickel or Pd sensitivity

Weight >105 Kg and/or height >185 cm

Known claustrophobia

Prior treatment with CAR-T therapy directed at any target

Trial design

Treatments tested in this trial

  • Combination Product: JNJ-68284528 (Cilta-cel) & 64Cu SPION dual PET-MR imaging agent

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators