NCT04290000

Collection of Biological Samples From Patients Treated With CAR-T Cells for Hematological Malignancies

Collection of Biological Samples From Patients Treated With CAR-T Cells for Hematological Malignancies in Montpellier University Hospital

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Development of CAR-T cell against CD19 B lymphoma and Acute Lymphoblastic Leukemia leaded to 2 authorized medication: Yescarta and Kymriah. Despite impressive outcomes in 3 phase II studies, never met in relapsed or refractory diseases, half of the patients don't respond to this treatment.This can be explained by a low expansion, functional alteration or short persistence of infused cells. Determination of reasons for treatment failure is the first step for optimization of this therapeutics. This project aims to bank blood samples from a cohort of patients treated with CAR-T cell for hematological malignancies in Montpellier University Hospital. Clinical data related to samples will be collected. This samples will be used to determine factors influencing efficacy of CAR-T cells treatments.

Detailed description

Development of CAR-T cell against CD19 B lymphoma and Acute Lymphoblastic Leukema leaded to 2 authorized medication: Yescarta and Kymriah. Despite impressive outcomes in 3 phase II studies, never met in relapsed or refractory diseases, half of the patients don't respond to this treatment.This can be explained by a low expansion, functional alteration or short persistance of infused cells. Determination of reasons for treatment failure is the first step for optimization of this therapeutics. This project aims to bank blood samples from a cohort of patients treated with CAR-T cell for hematological malignancies in Montpellier University Hospital. Clinical data related to samples will be collected. This samples will be used to determine factors influencing efficacy of CAR-T cells treatments.

Conditions

• Lymphoma and Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
OTHER	additional biological samples during CAR-T CELL treatment	Blood samples (additional tubes) and marrow (quantity taken in addition from the same aspiration) will be collected in addition to those useful for the follow up of the patients (progress of their disease after treatment with CAR-T Cells) at specific points in his treatment journey. The following samples will also be collected during Apheresis and at Car-T Cells reinjection : * Apheresis sampling * CAR-T Cells collected from bag rinsate In case of invasion, a skin biopsy will be made, 2 days and 8 days after the beginning of the CAR T Cell Treatment, during the patient's hospitalization and during a consultation visit in case of therapeutic progression or failure.

Timeline

• Start date: 2020-03-27
• Primary completion: 2025-09-27
• Completion: 2040-03-27
• First posted: 2020-02-28
• Last updated: 2025-07-10

Locations

1 site across 1 country: France