RecruitingNot ApplicableNCT06352242

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

La Trogocytose Est-elle un Marqueur prédictif de la réponse Aux Cellules CAR-T Dans Les Lymphomes Diffus à Grandes Cellules B ?

Sponsor

University Hospital, Montpellier

Enrollment

85 participants

Start Date

May 22, 2024

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma

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

Min Age: 18 Years

Inclusion Criteria15

For patients
Patient who has given free and informed consent in writing for inclusion in the non-interventional CART-BANK protocol, and orally for the CARTROG protocol,
Patients over 18 years of age at the time of inclusion,
Diagnosis of LDGCB,
Decision to treat with anti-CD19 CAR-T cells,
Patient affiliated to or benefiting from a social security scheme.
For healthy volunteers:
Given free and informed oral consent for inclusion in the CARTROG protocol,
Donor between 18 and 70 years of age at the time of inclusion,
No history of solid cancer or hematological malignancy,
No known chronic pathology (e.g. hypertension, diabetes, etc.) and no daily treatment,
No surgical treatment within the last 6 months.
Pregnant or breast-feeding patient,
Patient unable to follow the procedures and/or frequency of visits planned in the trial, for psychological, family, social or geographical reasons,
Patient unable to consent freely to inclusion, under guardianship, curatorship or safeguard of justice.

Interventions

OTHERFlow 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.

OTHERFlow 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.