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

ConditionExtramedullary Myeloma
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

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

    Biological/Vaccine

    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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Cilta-celExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
assessed up to one month (first month after infusion)

Secondary outcomes

1

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)

Time frame
From date of signing consent until study completion, assessed up to approximately 31 months
2

Complete response rate (CRR) by International Myeloma Working Group (IMWG) criteria

Using IMWG criteria

Time frame
assessed up to approximately 13 months
3

Overall response rate (ORR) by IMWG criteria

Using IMWG criteria

Time frame
assessed up to approximately 13 months
4

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

Time frame
assessed up to approximately 13 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peter MacCallum Cancer Centre, Australia

Lead sponsor

Janssen, LP

Collaborator

Source ClinicalTrials.gov
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