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

NCT05666700 | Recruiting Phase 1 DMC

• 1 other identifier: 21/015
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Extramedullary Myeloma

Outcome Measures

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

  assessed up to one month (first month after infusion)

Secondary Outcomes (7)

• Safety of 64Cu SPION labelled cilta-cel for EMM

  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

  assessed up to approximately 13 months

• Overall response rate (ORR) by IMWG criteria

  assessed up to approximately 13 months

• Minimal residual disease response by Adaptive ClonoSeq assay

  assessed up to approximately 13 months

• Duration of Response by IMWG criteria

  assessed up to approximately 13 months

Study Arms (1)

Cilta-cel

EXPERIMENTAL

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

Interventions

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

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

Cilta-cel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet all the following criteria for study entry:
• 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
• Have received at least 2 prior lines of therapy including a PTI and an IMiD. Patient must have undergone at least 1 complete cycle of treatment for each line of therapy, unless PD was the best response to the line of therapy (Appendix 2) Note: induction with or without haematopoietic stem cell transplant, consolidation and maintenance therapy is considered a single line of therapy.
• Have an ECOG Performance Status score of 0 or 1 (Appendix 3)
• Have a life expectancy of ≥3 months, as judged by the Investigator
• Able to undergo apheresis for mononuclear cell collection
• Have clinical laboratory values meeting the following criteria within 7 days prior to registration (enrolment):
• Haemoglobin ≥80g/L (recombinant human erythropoietin use is permitted)
• ANC ≥1 × 109/L (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test)
• Platelet count ≥50 × 109/L
• Absolute lymphocyte count ≥0.3 × 109/L
• AST ≤3.0× ULN

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from study entry:
• 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
• Received a cumulative dose of corticosteroids equivalent to ≥70mg of prednisone within the 7 days prior to planned apheresis
• Any prior therapy that is targeted to BCMA
• Vaccination with an investigational vaccine or live attenuated vaccine (except for COVID-19) within 4 weeks prior to planned conditioning
• Patient received any anti-tumour therapy as follows, prior to planned apheresis:
• Targeted therapy, epigenetic therapy, or treatment with an investigational drug or use of an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is less
• Investigational vaccine within 4 weeks
• Monoclonal antibody treatment within 21 days
• Cytotoxic therapy within 14 days
• Radiotherapy within 14 days. However, if the radiation is given for palliative purposes and the radiation portal covered ≤5% of the bone marrow reserve, the patient is eligible irrespective of the end date of radiotherapy
• Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are:

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead
• Janssen, LP: collaborator

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

Study Officials

• Simon Harrison

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Harrison

CONTACT

+61 03 8559 5373; Simon.Harrison@petermac.org

Mark Dowling

CONTACT

Mark.Dowling@petermac.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2022
• First Posted: December 28, 2022
• Study Start: December 8, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)