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NCT Number: NCT04290000

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

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.

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Key information

Conditions

Lymphoma and Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Département d'hématologie clinique

Montpellier, 34295, France

Location status: Recruiting

Location contact

Guillaume CARTRON, MD PHD

PRINCIPAL_INVESTIGATOR

Lamure a Sylvain, MD

CONTACT

[email protected]

0033467336733

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient treated by CAR-T cell at the University Hospital of Montpellier

Exclusion criteria

  • refusal to sign consent form
  • pregnant woman
  • major protected

Treatment and study plan

additional biological samples during CAR-T CELL treatment

Other

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.

Primary outcomes

  1. Constitution of biological samples from patient treated with CAR T cells

    Time frame: up to 15 years

    The aim is only to collect biological samples. This collection will be used later to determine factors influencing efficacy of CAR-T cells treatments.

    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 at specific points in his treatment and follow up.

    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.

Secondary outcomes

  1. patient survival

    Time frame: up to 15 years

    assessment of the patient survival

Study contacts

Contact information is provided by the study sponsor or research team.

Sylvain LAMURE, MD

CONTACT

[email protected]

0033467336733

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: CAR-T BANK

Important dates

Study start
2020
Primary completion
2025
Study completion
2040
First posted
Feb 28, 2020
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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