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Immunomonitoring and Predictive Biomarkers After CAR-T Cell Therapy in B-Cell Lymphoma and Multiple Myeloma
Sponsor: Centre Henri Becquerel
Summary
CARBIOM is a single-centre, non-randomized interventional study involving additional biological sampling with minimal risks and constraints. Up to 45 adults with relapsed or refractory B-cell lymphoma or multiple myeloma who are scheduled to receive standard-of-care anti-CD19 or anti-BCMA CAR-T cells will be enrolled. The study will characterize CAR-positive and endogenous CAR-negative T-cell populations and T-cell receptor clonality at apheresis, in the CAR-T product, at Day 7 +/- 3 days and at Month 1 +/- 7 days. These findings will be related to treatment response, toxicities and relapse during 12 months of follow-up. The study hypothesis is that dynamic immunological and molecular characteristics measured along the CAR-T pathway are associated with early response, toxicity and relapse risk.
Official title: Immunomonitoring and Identification of Predictive Biomarkers of Response, Toxicity and Risk of Relapse After CAR-T Cells in B-cell Lymphomas and Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2026-09-18
Completion Date
2028-11-02
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Interventions
Biological sample collection and immunomonitoring
Additional blood samples are collected at protocol-defined time points around standard-of-care CAR-T therapy, and stool samples are collected before lymphodepletion, at Month 1 and at Month 3. Analyses include spectral flow cytometry, T-cell receptor repertoire sequencing, routine flow cytometry, digital PCR, tumour molecular profiling and gut microbiota analyses. Standard-of-care CAR-T treatment is not assigned by the study.
Locations (1)
Centre Henri Becquerel
Rouen, Normandy, France