Clinical trial · Interventional
CAR-T Immunomonitoring in Multiple Myeloma (CART I5M)
CAR-T Immunomonitoring in Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Additional Bone Marrow cells and blood sampling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Other: Additional Bone Marrow cells and blood sampling
Primary outcomes (2)
- measure
- TCF-1 transcription factor (MFI) expression level in circulating CD3+ T cells
- timeFrame
- up to 1 year
- description
- 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
- measure
- 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)
- timeFrame
- Up to 1 year
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available