CAR-T Immunomonitoring in Multiple Myeloma (CART I5M)
ConditionMultiple Myeloma (MM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoitiers University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Additional Bone Marrow cells and blood sampling
Other interventionAdditional Bone Marrow cells and blood sampling
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: 1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
TCF-1 transcription factor (MFI) expression level in circulating CD3+ T cells
TCF-1 transcription factor (MFI) expression level in circulating CD3+ T cells at baseline and correlation with the percentage of CAR-BCMA+ T cells at different follow-up time points up to 1 year after CAR-BCMA treatment
Time frame
up to 1 year2
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)
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 yearSecondary outcomes
1
Stemness correlation with the persistence of CAR-BCMA lymphocytes and in the bone marrow at 3 months and 12 months after CAR-BCMA treatment
To determine whether stemness, reflected by the expression of the transcription factor TCF1 in T lymphocytes (CD3+) before apheresis and/or lymphodepletion, is correlated with the persistence of CAR-BCMA lymphocytes in the patient, in the bone marrow at 3 months and 12 months after CAR-BCMA treatment
Time frame
Up to 1 year2
Expression of membrane CD95 in peripheral blood
Identify the mechanisms of immune response homeostasis, reflected by the expression of membrane CD95L and early differentiation, interfering with the persistence of CAR-BCMA(+) T cells in peripheral blood at different time points over 12 months after CAR-BCMA treatment
Time frame
Up to 1 year3
Inflammatory profile of patients
To determine whether the inflammatory profile of patients, as determined by cytokine assays (sCD95L, IL-1β, IFN-γ, IL-6, IL-10, IL-15, and TNF-α) at each time point, is inversely correlated with the persistence of CAR-BCMA(+) T cells in the periphery and/or in the bone marrow
Time frame
Up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov