Is Trogocytosis a Predictive Marker of CAR-T Cell Response in Diffuse Large B-cell Lymphoma?

Condition(s) studied

Investigational drug(s) / intervention(s)

Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in patients: For each patient, a blood sample will be taken at D0 before the CAR-T cells are injected then at D3, D7, D10, D30 after the injection. Flow cytometry analysis will be performed on each sample on the day of collection to determine the level of trogocytosis by effector immune cells (T lymphocytes, NK cells, CAR-T cells) and to define the phenotypic "signature" of trogocytosis.

Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in volunteers: For each healthy volunteer, a single blood sample will be taken at enrollment. Flow cytometry analysis will be performed on each sample on the day of collection to determine the level of trogocytosis of normal lymphocytes and NK cells.

Study summary

CAR-T cell therapy has improved survival in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL R/R). However, only 65% of patients achieve a complete metabolic response after this treatment. To date, there is no predictive test for therapeutic response after injection of CAR-T cells. Recent studies have shown that the level of trogocytosis by immune cells correlates with the persistence of tumor cells in patients with hematological malignancies. Our main objective is to identify a phenotypic "signature" of trogocytosis predictive of therapeutic response 6 months after injection of CAR-T cells for DLBCL.

Eligibility

Primary outcome measure(s)

• Identification of a phenotypic "signature" of trogocytosis predictive of failure to achieve a complete metabolic response for patients with diffuse large B-cell lymphoma. — During 6 months after CAR-T cells injection
  Using flow cytometry to determine the level of trogocytosis, the phenotypic "signature" of trogocytosis will be assessed by the AUC : area under the ROC (Receiver operating characteristic) curve; established on circulating CAR-T cells, T lymphocytes and NK cells of patients, and defined as: the percentage of cells aberrantly expressing different tumor antigens normally expressed on lymphoma cells (CD19, CD20, etc.) at the different analysis times and/or the median florescence intensity (MFI) of the expression of these markers at the different analysis times and/or the evolution of these percentages and the MFI between 2 analysis times. Failure to obtain a complete metabolic response will be defined by: the absence of a complete metabolic response on the PET scans of D30, D90 and M6 in the absence of implementation of a new therapeutic line; or by the absence of complete metabolic response on all PET scans carried out before the implementation of a new therapeutic line.

Trial sites (2)

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