Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352242
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-03-26
Brief Title:
Is Trogocytosis a Predictive Marker of CAR-T Cell Response in Diffuse Large B-cell Lymphoma
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
La Trogocytose Est-elle un Marqueur prédictif de la réponse Aux Cellules CAR-T Dans Les Lymphomes Diffus à Grandes Cellules B
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARTROG
Brief Summary:
CAR-T cell therapy has improved survival in patients with relapsed or refractory diffuse large B-cell lymphoma DLBCL RR 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
Detailed Description:
The therapeutic use of CAR-T cells Chimeric Antigen Receptor T-cells has significantly improved the survival of patients with relapsed or refractory RR diffuse large B-cell lymphoma DLBCL However only 65 of patients achieve metabolic complete response after this treatment and one year after CAR-T cells infusion between 50 and 60 of patients have relapsed or died Injection of CAR-T cells can also be responsible for serious immunologic and hematologic adverse events To date there is no predictive test for the therapeutic response or toxicity following injection of CAR-T cells
Trogocytosis is a physiological mechanism by which an effector immune cell integrates fragments of the membrane of target cells into its membrane These aberrant membrane markers can directly modify the functions of the cell that has acquired them Although the physiological role of trogocytosis remains debated recent studies have shown that the level of trogocytosis in immune effector cells is correlated with persistent tumor cells in patients with hematological malignancies
Our main hypothesis is that in DLBCL the level of early trogocytosis assessed by the aberrant expression of tumor markers on the surface of CAR-T cells and other immune effector cells between D0 and D30 after CAR-T cells infusion correlates with therapeutic response at M6 andor the occurrence of immunological or severe hematological CAR-T cells side-effects
Trogocytosis is a physiological mechanism by which an effector immune cell integrates fragments of the membrane of target cells into its membrane These aberrant membrane markers can directly modify the functions of the cell that has acquired them Although the physiological role of trogocytosis remains debated recent studies have shown that the level of trogocytosis in immune effector cells is correlated with persistent tumor cells in patients with hematological malignancies
Our main hypothesis is that in DLBCL the level of early trogocytosis assessed by the aberrant expression of tumor markers on the surface of CAR-T cells and other immune effector cells between D0 and D30 after CAR-T cells infusion correlates with therapeutic response at M6 andor the occurrence of immunological or severe hematological CAR-T cells side-effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None