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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional Bone Marrow cells and blood sampling | Other | Additional Bone Marrow cells and blood sampling |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 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) | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ARTHUR BOBIN | Contact | 0033549444201 | arthur.bobin@chu-poitiers.fr | |
| STEPHANIE NOEL | Contact | 0033549443083 | stephanie.noel@chu-poitiers.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Poitiers | Recruiting | Poitiers | 86000 | France |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 28, 2025 | Dec 31, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Prospective interventional study with minimal risks and constraints, descriptive, exploratory, non-randomized, longitudinal, single-center, basic research aim.
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| Up to 1 year |
| 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 | Up to 1 year |
| 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 | Up to 1 year |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |