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Recruiting NCT07342179

CAR-T Immunomonitoring in Multiple Myeloma (CART I5M)

No phase Interventional Multiple Myeloma (MM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Additional Bone Marrow cells and blood sampling.
Who it may be relevant to
Registry conditions: Multiple Myeloma (MM). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

CAR-T Immunomonitoring in Multiple Myeloma

Overview

Multiple myeloma patients can be treated with cell therapy, which uses some of their own modified white blood cells (T lymphocytes) to target a protein (BCMA, or B-cell maturation antigen) found on the surface of the myeloma plasma cells. These modified T lymphocytes are called CAR T cells (chimeric antigen receptor T cells). The long-term persistence of these modified lymphocytes, or CAR-BCMA, is a recognized indicator of a good response to treatment. This research aims to study certain markers related to CAR-BCMA cell persistence. This research will be carried out in collaboration with the Laboratory of Ischemia Reperfusion, Metabolism and Sterile Inflammation in Transplantation (IRMETIST) INSERM unit U1313, located at the University of Poitiers. The proposed project will contribute to better patient care in the field of oncology, by identifying immunological cellular markers predictive of an effective response to anti-cancer treatments and/or immunotherapeutic targeting.

Detailed description

Multiple myeloma data will be collected from initial diagnosis and relapses, treatments receive since initial diagnosis and the CAR-T therapy (start of CAR-T therapy, type of CAR-T, responder status). Before and up to 1 year after CART C Cells treatment, blood (7) and bone marrow (3) samples will be sent to a centralised laboratories to analyse immune cells, including CAR-BCMA cells, and measure the expression of certain proteins on their surface (CD95 and CD95L) and the serum-soluble CD95L protein.

Interventions

  • Other Additional Bone Marrow cells and blood sampling
    Additional Bone Marrow cells and blood sampling

Primary outcome measures

  • TCF-1 transcription factor (MFI) expression level in circulating CD3+ T cells [Time frame: up to 1 year]
  • TCF-1 transcription factor (MFI) expression level in correlation with the depth of the patient's response as defined by international guidelines (IMS/IMWG criteria) [Time frame: Up to 1 year]
Secondary outcome measures (3)
  • Stemness correlation with the persistence of CAR-BCMA lymphocytes and in the bone marrow at 3 months and 12 months after CAR-BCMA treatment [Time frame: Up to 1 year]
  • Expression of membrane CD95 in peripheral blood [Time frame: Up to 1 year]
  • Inflammatory profile of patients [Time frame: Up to 1 year]

Eligibility criteria

Inclusion criteria

  • Patient aged 18 and over
  • Patient with Multiple Myeloma according to international recommendations,
  • Patient about to receive CAR-T cell therapy in accordance with the rules and authorizations in France.

Exclusion criteria

  • Patients with severely impaired physical and/or psychological health, which, according to the investigator, may affect the participant's compliance with the study.
  • Simultaneous participation in another study with an ongoing exclusion period.
  • Individuals receiving enhanced protection, namely minors, pregnant and/or breastfeeding women, individuals deprived of their liberty by a judicial or administrative decision, individuals residing in a healthcare or social care facility, adults under legal guardianship, and finally, patients in emergency situations

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

France · 1 center
  • Chu de Poitiers — Poitiers

Identifiers

NCT: NCT07342179 · 2025-A01924-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗