Impact of Treatment With Targeted Therapies on the Generation of CAR T Cells in CLL Patients
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|ClinicalTrials.gov Identifier: NCT04640909|
Recruitment Status : Not yet recruiting
First Posted : November 23, 2020
Last Update Posted : March 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|CLL Chronic Lymphocytic Leukemia||Other: Peripheral blood samples withdrawal||Not Applicable|
This is a biological study aimed at analyzing the features of CAR T cells generated in CLL patients treated with ibrutinib or venetoclax.
To this purpose, blood samples will be collected from patients with CLL before starting therapy with ibrutinib or venetoclax and after 6 and 12 months of treatment.
Anti-CD19 CAR T cells will be generated and tested for: (i) viability, expansion and generation efficiency; (ii) phenotypic characteristics, in terms of CD4/CD8 composition, differentiation subset distribution, exhaustion markers and expression of immune checkpoint molecules; (iii) in vitro functional properties, in terms of proliferation ability, cytokines production, cytotoxic activity and killing of target cells. CAR T cells produced from the same patient at different timepoints will be compared. Phenotypic and functional data on CAR T cells will be also correlated with main CLL prognostic factors (e.g. IGHV mutational status, FISH abnormalities, TP53 mutation status) and outcome variables (response status, duration of response).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Impact of Treatment With Targeted Therapies on the Generation of Effective CAR T Cells in Patients With Chronic Lymphocytic Leukemia|
|Estimated Study Start Date :||April 2021|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||April 2024|
CAR T Cells generation
CAR T Cells generation at baseline and after 6 and 12 months of treatment
Other: Peripheral blood samples withdrawal
Peripheral blood samples evaluation
- Cell killing rate of anti-CD19 CAR T cells [ Time Frame: After 12 months of treatment ]Assessment of the cytotoxic functions of anti-CD19 CAR T cells generated from CLL patients in terms of cell killing rate before and during treatment with targeted agents (i.e. ibrutinib or venetoclax).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04640909
|Contact: Paola Faziemail@example.com|
|Contact: Enrico Creafirstname.lastname@example.org|