Delving into the Latest Updates on Anti-CD19 CAR-T cell therapy(The First Affiliated Hospital of Nanchang University) with Synapse

Overview

Basic Info

Drug Type

CAR-T

Synonyms-

Target

CD19

Action

inhibitors

Mechanism

CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), Gene transference

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication-

Inactive Indication

LymphomaRefractory B Acute Lymphoblastic LeukemiaRefractory Multiple Myeloma+ [1]

Originator Organization

The First Affiliated Hospital of Nanchang University

Active Organization-

Inactive Organization

The First Affiliated Hospital of Nanchang University

License Organization-

Drug Highest PhasePendingPhase 1/2

First Approval Date-

Regulation-

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Anti-CD19 chimeric antigen receptor (CAR) T-cell therapies, including axicabtagene ciloleucel (axi-cel) and brexucabtagene autoleucel (brexu-cel), have demonstrated significant efficacy in treating B-cell malignancies, accompanied by manageable safety profiles.However, a rare incidence of subsequent T-cell malignancies has been observed in patients undergoing axi-cel therapy.The Gilead Global Safety Database, covering clin. trials and postauthorization studies, reported a 0.07% rate of T-cell malignancies post-axi-cel infusion, consistent with background risks in B-cell malignancy populations.Mol. analyses of available tumor samples revealed no causality between CAR transgenes and malignancy development.No T-cell malignancies were associated with brexu-cel therapy.Hese findings underscore the necessity of ongoing surveillance to refine risk assessments while affirming the pos. benefit-risk profile of these therapies.

01 Aug 2024·Chaos: An Interdisciplinary Journal of Nonlinear Science

Understanding the role of B cells in CAR T-cell therapy in leukemia through a mathematical model

Article

Author: Martínez-Rubio, Álvaro ; Belmonte-Beitia, Juan ; Serrano, Sergio ; Pérez-García, Víctor M. ; Barrio, Roberto

Chimeric antigen receptor T (CAR T) cell therapy has been proven to be successful against a variety of leukemias and lymphomas. This paper undertakes an analytical and numerical study of a mathematical model describing the competition of CAR T, leukemia, tumor, and B cells. Considering its significance in sustaining anti-CD19 CAR T-cell stimulation, a B-cell source term is integrated into the model. Through stability and bifurcation analyses, the potential for tumor eradication, contingent on the continuous influx of B cells, has been revealed, showing a transcritical bifurcation at a critical B-cell input. Additionally, an almost heteroclinic cycle between equilibrium points is identified, providing a theoretical basis for understanding disease relapse. Analyzing the oscillatory behavior of the system, the time-dependent dynamics of CAR T cells and leukemic cells can be approximated, shedding light on the impact of initial tumor burden on therapeutic outcomes. In conclusion, the study provides insights into CAR T-cell therapy dynamics for acute lymphoblastic leukemias, offering a theoretical foundation for clinical observations and suggesting avenues for future immunotherapy modeling research.

03 Jul 2024·Acta Clinica Belgica

Single center, real-world retrospective study of CAR-T cell therapy for relapsed/refractory large B-cell lymphoma beyond second line: five-year results at the University Hospitals Leuven

Article

Author: Vandenberghe, Peter ; Dubois, Benedicte ; Dierickx, Daan ; Sinap, Franky ; Van Ham, Jonas ; Brijs, Jan ; Vergote, Vibeke

INTRODUCTIONLarge B-cell lymphomas (LBCL) are the most frequently aggressive B-cell non-Hodgkin lymphomas. Anti-CD19 chimeric antigen receptor (CAR)-T cell therapy has emerged as a new, powerful treatment for relapsed or refractory (R/R) disease. Two CAR-T cell products, tisagenlecleucel (tisa-cel,) and axicabtagene ciloleucel (axi-cel), are reimbursed in Belgium for R/R LBCL beyond second line.OBJECTIVES AND METHODSWe conducted a retrospective cohort study to report the outcome with tisa-cel and axi-cel for R/R LBCL beyond second line in the years 2019-2023 at the University Hospitals Leuven for 79 patients selected for apheresis and CAR-T infusion.RESULTSEleven patients (14%) did not proceed to CAR-T cell infusion. For infused patients (n = 68), the best overall response rate (ORR)/complete response (CR) rate was 64%/49% for tisa-cel and 88%/66% for axi-cel (p = 0.04 for ORR). After a median follow-up of 13.8 months, progression-free survival (PFS) and overall survival (OS) at 1 year were 30% and 43% for tisa-cel and 48% and 62% for axi-cel. Cytokine release syndrome (CRS) (all grades/grade ≥3) occurred in 82%/9% after tisa-cel and in 97%/0% after axi-cel. Immune effector cell-associated neurotoxicity syndrome (ICANS) (all grades/grade ≥3) occurred in 24%/18% after tisa-cel and in 54%/40% after axi-cel. The non-relapse mortality in the infusion cohort was 13%.CONCLUSIONOur real-world data show high and durable response rates, with a non-significant trend towards a higher efficacy and higher toxicity for axi-cel compared to tisa-cel. Our results are in line with other real-world registries except for a shorter median OS and more high-grade ICANS.

100 Deals associated with Anti-CD19 CAR-T cell therapy(The First Affiliated Hospital of Nanchang University)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lymphoma	Phase 2	China	The First Affiliated Hospital of Nanchang University	01 Dec 2019
Refractory B Acute Lymphoblastic Leukemia	Phase 2	China	The First Affiliated Hospital of Nanchang University	01 Dec 2019
Refractory Multiple Myeloma	Phase 2	China	The First Affiliated Hospital of Nanchang University	01 Dec 2019
Relapse multiple myeloma	Phase 2	China	The First Affiliated Hospital of Nanchang University	01 Dec 2019