Delving into the Latest Updates on SNUH-CD19-CAR-T(Seoul National University Hospital) with Synapse

Overview

Basic Info

Drug Type

Autologous CAR-T

Synonyms

CD19 Chimeric Antigen Receptor T Cells(Seoul National University Hospital)

Target

CD19

Action

modulators

Mechanism

CD19 modulators(B-lymphocyte antigen CD19 modulators), Immunologic cytotoxicity, T lymphocyte replacements

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [4]

Active Indication

Carney ComplexCD19-positive B-cell acute lymphoblastic leukemiaCD19 positive Acute Lymphoblastic Leukemia+ [1]

Inactive Indication-

Originator Organization

Seoul National University Hospital

Active Organization

Seoul National University Hospital

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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This is a phase 2 clinical trial targeting pediatric and adolescent patients diagnosed with CD19-positive B-ALL, considered very high-risk group. The study aims to administer CD19 CAR-T therapy as an alternative to hematopoietic stem cell transplantation in patients eligible for such transplantation. The trial includes patients aged 25 or younger.

Start Date19 Jan 2024

Sponsor / Collaborator

Seoul National University Hospital

KCT0009475

/ RecruitingNot ApplicableIIT

Long-Term Safety and Efficacy Assessment through Longitudinal Follow-Up of Pediatric and Adolescent Patients Receiving SNUH-CD19-CAR-T for CD19-Positive B-Cell Malignancies

Start Date28 Jun 2023

Sponsor / Collaborator

Seoul National University Hospital

NCT05210907

/ RecruitingPhase 1IIT

A Phase Ib, Clinical Trial of Hospital-manufactured CD19 Chimeric Antigen Receptor T Cells (SNUH-CD19-CAR-T) in Children and Adolescents With Relapsed or Refractory CD19 Positive Acute Lymphoblastic Leukemia

Chimeric antigen receptor T cells (CAR-T cells) have been developed to treat relapsed and refractory hematological malignancies with promising outcome in patients with very poor prognosis. The purpose of this clinical study is to produce the CD19[cluster of differentiation antigen 19] CAR-T (SNUH-CD19-CAR-T) at the investigational site and to evaluate safety and efficacy of SNUH-CD19-CAR-T in children and adolescent with relapsed/refractory B-cell acute lymphoblastic leukemia.

Start Date15 Feb 2022

Sponsor / Collaborator

Seoul National University Hospital

100 Clinical Results associated with SNUH-CD19-CAR-T(Seoul National University Hospital)

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100 Translational Medicine associated with SNUH-CD19-CAR-T(Seoul National University Hospital)

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100 Patents (Medical) associated with SNUH-CD19-CAR-T(Seoul National University Hospital)

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35

Literatures (Medical) associated with SNUH-CD19-CAR-T(Seoul National University Hospital)

01 Sep 2024·British Journal of Haematology

Atrial arrhythmias following CAR‐chimeric antigen receptor T‐cell therapy: Incidence, risk factors and biomarker profile

Article

Author: Geyer, Mark B. ; El‐Moghraby, Ahmed ; Shah, Gunjan L. ; Palomba, M. Lia ; Landego, Ivan ; Lin, Richard J. ; Rehman, Mahin ; Walji, Moneeza ; Devlin, Sean M. ; Raj, Sandeep S. ; Kosmidou, Ioanna ; Mahmood, Syed S. ; Giralt, Sergio A. ; Salles, Gilles ; Perales, Miguel‐Angel ; Dahi, Parastoo B. ; Goldman, Adam ; Corona, Magdalena ; Scordo, Michael ; Shouval, Roni ; Nath, Karthik ; Liu, Jennifer E. ; Flynn, Jessica R. ; Fein, Joshua A. ; Park, Jae H.

SummaryRecent reports have raised concerns about the association of chimeric antigen receptor T cell (CAR‐T) with non‐negligible cardiotoxicity, particularly atrial arrhythmias. First, we conducted a pharmacovigilance study to assess the reporting of atrial arrhythmias following CD19‐directed CAR‐T. Subsequently, to determine the incidence, risk factors and outcomes of atrial arrhythmias post‐CAR‐T, we compiled a retrospective single‐centre cohort of non‐Hodgkin lymphoma patients. Only commercial CAR‐T products were considered. Atrial arrhythmias were nearly fourfold more likely to be reported after CAR‐T therapy compared to all other cancer patients in the FAERS (adjusted ROR = 3.76 [95% CI 2.67–5.29]). Of the 236 patients in our institutional cohort, 23 (10%) developed atrial arrhythmias post‐CAR‐T, including 12 de novo arrhythmias, with most (83%) requiring medical intervention. Atrial arrhythmias frequently co‐occurred with cytokine release syndrome and were associated with higher post‐CAR‐T infusion peak levels of IL‐10, TNF‐alpha and LDH, and lower trough levels of fibrinogen. In a multivariable analysis, risk factors for atrial arrhythmia were history of atrial arrhythmia (OR = 6.80 [2.39–19.6]) and using CAR‐T product with a CD28‐costimulatory domain (OR = 5.17 [1.72–18.6]). Atrial arrhythmias following CD19‐CAR‐T therapy are prevalent and associated with elevated inflammatory biomarkers, a history of atrial arrhythmia and the use of a CAR‐T product with a CD28 costimulatory domain.

25 Jun 2024·Blood Advances

Postinfusion PD-1+ CD8+ CAR T cells identify patients responsive to CD19 CAR T-cell therapy in non-Hodgkin lymphoma

Article

Author: Voorhees, Timothy J. ; Wang, Yi ; Jaglowski, Samantha ; Chan, Wing Keung ; Hanel, Walter ; Miao, Jessica ; Bezerra, Evandro ; Denlinger, Nathan ; Epperla, Narendranath ; Reynolds, Kelsi ; Wu, Dayong ; Baiocchi, Robert A. ; Zhang, Xiaoli ; Song, Chunhua ; Li, Zihai ; Sigmund, Audrey ; Sawalha, Yazeed ; de Lima, Marcos ; Vasu, Sumithira ; Jeon, Hyeongseon ; Reneau, John C. ; Kittai, Adam S. ; Alinari, Lapo ; Rubinstein, Mark P. ; Bolz, Robert M. ; Brammer, Jonathan ; Bond, David A. ; Maddocks, Kami ; Peterson, Chelsea ; Huang, Xiaopei ; Chung, Dongjun ; Song, No-Joon ; Christian, Beth ; Yang, Yiping

AbstractChimeric antigen receptor (CAR) T-cell therapy has revolutionized treatment for relapsed/refractory B-cell non-Hodgkin lymphoma (NHL). Robust biomarkers and a complete understanding of CAR T-cell function in the postinfusion phase remain limited. Here, we used a 37-color spectral flow cytometry panel to perform high dimensional single-cell analysis of postinfusion samples in 26 patients treated with CD28 costimulatory domain containing commercial CAR T cells for NHL and focused on computationally gated CD8+ CAR T cells. We found that the presence of postinfusion Programmed cell death protein 1 (PD-1)+ CD8+ CAR T cells at the day 14 time point highly correlated with the ability to achieve complete response (CR) by 6 months. Further analysis identified multiple subtypes of CD8+ PD-1+ CAR T cells, including PD-1+ T cell factor 1 (TCF1)+ stem-like CAR T cells and PD-1+ T-cell immunoglobulin and mucin-domain containing-3 (TIM3)+ effector-like CAR T cells that correlated with improved clinical outcomes such as response and progression-free survival. Additionally, we identified a subset of PD-1+ CD8+ CAR+ T cells with effector-like function that was increased in patients who achieved a CR and was associated with grade 3 or higher immune effector cell–associated neurotoxicity syndrome. Here, we identified robust biomarkers of response to CD28 CAR T cells and highlight the importance of PD-1 positivity in CD8+ CAR T cells after infusion in achieving CR.

01 Feb 2024·Bone Marrow Transplantation

Efficacy of CD19 directed therapies in patients with relapsed or refractory large b-cell lymphoma relapsing after CD19 directed chimeric antigen receptor T-cell therapy

Article

Author: Maakaron, Joseph E ; Fijalka, Andrew ; Craver, Emily ; Khurana, Arushi ; Li, Zhuo ; Epperla, Narendranath ; Bhaskar, Shakthi T ; Annunzio, Kaitlin ; Jagadeesh, Deepa ; Chavez, Julio ; Iqbal, Madiha ; Isufi, Iris ; Dholaria, Bhagirathbhai R ; Lin, Yi ; Kharfan-Dabaja, Mohamed A ; Rosenthal, Allison ; Mishra, Rahul ; Sandoval-Sus, Jose D ; Awan, Farrukh T ; Sumransub, Nuttavut ; Saha, Aditi ; Ivanov, Stanislav A

Outcomes are poor for patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) post chimeric antigen receptor T-cell (CAR-T) therapy. Two CD19-directed therapies, tafasitamab- cxix plus lenalidomide (tafa-len) and loncastuximab tesirine (loncaT) are approved in R/R LBCL. The efficacy of these CD19 directed therapies in patients who relapse after CD19 directed CAR-T (CD19-CART) therapy is not well understood. We conducted a multi-center study of patients with R/R LBCL that received either tafa-len or loncaT at any timepoint for R/R disease after CD19-CART therapy. Fifty-three patients were included in this study with the median follow up of 56 (9.1-199) weeks from CAR-T infusion. Median number of systemic therapies pre-CAR-T therapy was 3 (range: 1-6); axicabtagene ciloleucel was the most utilized CAR-T product (n = 32,60%). Median time from CAR-T therapy to tafa-len or loncaT was 7.3 (1.2-38.2) months with median number of lines of therapy between CAR-T therapy and these regimens of 1 (0-5). Combined overall response rate and complete response rates were 27% and 10%, respectively. Median duration of response was 13.3 (2.1-56.7) weeks. In this real-world study, the use of currently approved CD19-directed therapies to treat R/R LBCL after CD19-CAR-T therapy showed limited clinical activity and duration of responses.

100 Deals associated with SNUH-CD19-CAR-T(Seoul National University Hospital)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Carney Complex	Phase 2	South Korea	Seoul National University Hospital	19 Jan 2024
CD19-positive B-cell acute lymphoblastic leukemia	Phase 2	South Korea	Seoul National University Hospital	19 Jan 2024
CD19 positive Acute Lymphoblastic Leukemia	Phase 1	South Korea	Seoul National University Hospital	15 Feb 2022
Pre B-cell acute lymphoblastic leukemia	Phase 1	South Korea	Seoul National University Hospital	15 Feb 2022