CAR-T Immunomonitoring in Multiple Myeloma (CART I5M)

Официальное название

CAR-T Immunomonitoring in Multiple Myeloma

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• TCF-1 transcription factor (MFI) expression level in circulating CD3+ T cells [Срок оценки: 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) [Срок оценки: Up to 1 year]

Вторичные конечные точки (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 [Срок оценки: Up to 1 year]
• Expression of membrane CD95 in peripheral blood [Срок оценки: Up to 1 year]
• Inflammatory profile of patients [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 1 центр

• Chu de Poitiers — Poitiers

Идентификаторы

NCT: NCT07342179 · 2025-A01924-45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗