Actively Recruiting
CAR-T Immunomonitoring in Multiple Myeloma
Led by Poitiers University Hospital · Updated on 2026-02-18
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with multiple myeloma, a type of cancer affecting plasma cells, to better understand immune responses to a type of cell therapy called CAR-T therapy. This therapy modifies a patient's own white blood cells (T lymphocytes) to target a protein called BCMA found on myeloma cells. The study aims to identify markers linked to the persistence of these modified CAR-BCMA cells, which is considered an indicator of a good treatment response. This research is conducted in partnership with the Laboratory of Ischemia Reperfusion, Metabolism and Sterile Inflammation in Transplantation (IRMETIST) at the University of Poitiers. Participants will have data collected from their initial diagnosis, any relapses, treatments received, and details about their CAR-T therapy including start date and responder status. Blood and bone marrow samples will be taken before and for up to one year after CAR-T treatment. These samples will be analyzed in centralized labs to study immune cells, including CAR-BCMA cells, and measure proteins on their surface such as CD95 and CD95L, along with the serum-soluble CD95L protein. During the study, participants will provide blood samples at seven different times and bone marrow samples at three different times over the course of one year following CAR-T treatment. Researchers will measure outcomes including TCF-1 transcription factor levels in circulating T cells and their correlation with patient response depth. Secondary measures include stem cell characteristics, CAR-BCMA cell persistence in bone marrow, membrane CD95 expression in blood, and inflammatory profiles. The study includes ongoing monitoring for up to one year from CAR-T therapy start.
CONDITIONS
Brief Title
CAR-T Immunomonitoring in Multiple Myeloma (CART I5M)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 and over
- Patient diagnosed with Multiple Myeloma according to international recommendations
- Patient about to receive CAR-T cell therapy in accordance with regulations in France
You will not qualify if you...
- Severely impaired physical and/or psychological health affecting study compliance
- Participation in another study with an ongoing exclusion period
- Individuals under enhanced protection, including minors, pregnant or breastfeeding women, those deprived of liberty by judicial or administrative decision, residents in healthcare or social care facilities, adults under legal guardianship, and patients in emergency situations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 1 year
Participants undergo blood and bone marrow sampling before and up to 1 year after CAR-T cell therapy to analyze immune cells and protein expression.
Approximately 10 visits for blood and bone marrow sampling
Trial Site Locations
Total: 1 location
1
Chu de Poitiers
Poitiers, France, 86000
Actively Recruiting
Research Team
A
ARTHUR BOBIN
S
STEPHANIE NOEL
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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