CAR-T Immunomonitoring in Multiple Myeloma (CART I5M)

Poitiers University Hospital

Status

Not yet enrolling

Conditions

Multiple Myeloma (MM)

Treatments

Other: Additional Bone Marrow cells and blood sampling

Study type

Interventional

Funder types

Other

Identifiers

NCT07342179

2025-A01924-45

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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