细胞治疗用于 B 细胞淋巴瘤：注册临床试验（分期未知）（Centre Henri Becquerel）

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.

主要终点：Longitudinal CAR-positive and CAR-negative T-cell phenotype and T-cell receptor clonality associated with Month 1 response · 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. · Apheresis; CAR-T product before infusion; Day 7 after infusion ; Month 1 after infusion. Therapeutic response is assessed at Month 1.
次要终点：Secondary imaging outcomes after CAR-T cell infusion；Secondary clinical outcomes after CAR-T cell infusion；Bridge treatment received；secondary immunological outcome after CAR-T cell infusion；Secondary micobiota outcome；Secondary molecular outcome

• CARBIOM cohort · OTHER · Adults receiving standard-of-care anti-CD19 or anti-BCMA CAR-T cell therapy undergo protocol-specific biological sampling and longitudinal immunomonitoring. CAR-T treatment is not assigned by the study.

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.