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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age 18 years or older.
* Relapsed or refractory B-cell lymphoma or multiple myeloma.
* Indication for anti-CD19 or anti-BCMA CAR-T cell treatment.
* Signed informed consent.
* Affiliation to or beneficiary status under a health insurance scheme.
Exclusion Criteria:
* Previous exposure to anti-BCMA bispecific antibodies or need for anti-BCMA bispecific antibodies as bridging therapy before anti-BCMA CAR-T cell administration.
* Pregnant or breastfeeding.
* Absence of informed consent.
* Primary central nervous system lymphoma or primary vitreoretinal lymphoma.
* Body weight below 30 kg.
* Protected adult or person deprived of liberty under guardianship or curatorship.
* Inability to understand the study or comply with study constraints for language, psychological, geographical or other reasons.
Primary outcome measure(s)
Longitudinal CAR-positive and CAR-negative T-cell phenotype and T-cell receptor clonality associated with Month 1 response — Apheresis; CAR-T product before infusion; Day 7 after infusion ; Month 1 after infusion. Therapeutic response is assessed at Month 1. Longitudinal characterisation of expansion and decline kinetics, activation, differentiation and exhaustion profiles, and T-cell receptor repertoire diversity, clonality and persistence by spectral flow cytometry and sequencing. Parameters will be compared between responders and non-responders at Month 1 using Lugano 2014 criteria for B-cell lymphomas or International Myeloma Working Group criteria for multiple myeloma.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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