Delving into the Latest Updates on CAR-T-19(Immunotech Biopharm) with Synapse

Overview

Basic Info

Drug Type

Autologous CAR-T

Synonyms-

Target

CD19

Mechanism

CD19 modulators(B-lymphocyte antigen CD19 modulators)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases

Active Indication

Recurrent B Acute Lymphoblastic LeukemiaRefractory B Acute Lymphoblastic LeukemiaCD19-positive B-cell acute lymphoblastic leukemia+ [2]

Inactive Indication-

Originator Organization

Immunotech Biopharm Ltd

Active Organization

Beijing Yongtai Ruike Biotechnology Co. Ltd.

Immunotech Biopharm Ltd

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Primary objective: To evaluate the effectiveness of CAR-T-19 in the treatment of subjects with CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia. Secondary objective: To evaluate the safety, PK characteristics, and PD characteristics of CAR-T-19 in subjects with CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.

Start Date28 Dec 2023

Sponsor / Collaborator

Beijing Yongtai Ruike Biotechnology Co. Ltd.

ChiCTR1900024218 / RecruitingEarly Phase 1IIT

CAR-T-19-DNR/ CAR-T-19 in the treatment of cd19-positive relapsed/refractory diffuse large b-cell lymphoma: an open, parallel explore clinical study

Start Date01 Aug 2019

Sponsor / Collaborator-

100 Clinical Results associated with CAR-T-19(Immunotech Biopharm)

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100 Translational Medicine associated with CAR-T-19(Immunotech Biopharm)

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100 Patents (Medical) associated with CAR-T-19(Immunotech Biopharm)

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86

Literatures (Medical) associated with CAR-T-19(Immunotech Biopharm)

25 Jul 2024·The Journal of Infectious Diseases

Immunologic Predictors of Vaccine Responsiveness in Patients With Lymphoma and Chronic Lymphocytic Leukemia

Article

Author: Adamski, Sharon ; Barta, Stefan K ; Weirick, Madison E ; Hensley, Scott E ; Gupta, Aditi ; Greenplate, Allison R ; John, Gavin N ; Hicks, Amanda ; Gaano, Andrew ; Awofolaju, Moses ; Walsh, Kristy M ; Gerson, James N ; Lundberg, Rachel K ; Chong, Emeline R ; Svoboda, Jakub ; Chong, Elise A ; Ruella, Marco ; Lundgreen, Kendall A ; Kumashie, Kingsley Gideon ; Pattekar, Ajinkya ; Korte, Scott ; Sharma, Harsh ; Hamilton, Jacob T ; Tanenbaum, Nicole ; Pajarillo, Raymone ; Vella, Laura A ; D’Andrea, Kurt ; Schuster, Stephen J ; Herring, Sarah ; Fabrizio, Joseph ; Williams, Justine C ; Gouma, Sigrid ; Wherry, E John ; Prak, Eline T Luning ; Gonzalez, Joyce ; Napier, Ellen B ; Drapeau, Elizabeth M ; Landsburg, Daniel J ; Novacek, Josef ; McAllister, Christopher M ; Nasta, Sunita D ; Kammerman, Shane C ; Bates, Paul

AbstractPatients with B-cell lymphomas have altered cellular components of vaccine responses due to malignancy and therapy, and the optimal timing of vaccination relative to therapy remains unknown. Severe acute respiratory syndrome coronavirus 2 vaccines created an opportunity for new insights in vaccine timing because patients were challenged with a novel antigen across multiple phases of treatment. We studied serologic messenger RNA vaccine response in retrospective and prospective cohorts with lymphoma and chronic lymphocytic leukemia, paired with clinical and research immune parameters. Reduced serologic response was observed more frequently during active treatment, but nonresponse was also common within observation and posttreatment groups. Total immunoglobulin A and immunoglobulin M correlated with successful vaccine response. In individuals treated with anti-CD19–directed chimeric antigen receptor–modified T cells, nonresponse was associated with reduced B and T follicular helper cells. Predictors of vaccine response varied by disease and therapeutic group, and therefore further studies of immune health during and after cancer therapies are needed to individualize vaccine timing.

15 Jul 2024·Cancer Research and Treatment

CD19-Specific CAR-T Cell Treatment of 115 Children and Young Adults with Acute B Lymphoblastic Leukemia: Long-term Follow-up

Article

Author: Zuo, Ying-Xi ; Jia, Yue-Ping ; Zhang, Le-Ping ; Xue, Yu-Juan ; Zeng, Hui-Min ; Lu, Ai-Dong ; Wang, Yu

Purpose Chemotherapy has been the primary treatment for patients with B-cell acute lymphoblastic leukemia (B-ALL). However, there are still patients who are not sensitive to chemotherapy, including those with refractory/relapse (R/R) disease and those experiencing minimal residual disease (MRD) re-emergence. Chimeric antigen receptor-T lymphocytes (CAR-T) therapy may provide a new treatment option for these patients.Materials and Methods Our institution conducted a single-arm prospective clinical trial (ChiCTR-OPN-17013507) using CAR-T-19 to treat R/R B-ALL and MRD re-emergent patients. One hundred and fifteen patients, aged 1-25 years (median age, 8 years), were enrolled, including 67 R/R and 48 MRD re-emergent CD19-positive B-ALL patients.Results All patients achieved morphologic complete remission (CR), and within 1 month after infusion, 111 out of 115 (96.5%) patients achieved MRD-negative CR. With a median follow-up time of 48.4 months, the estimated 4-year leukemia-free survival (LFS) rate and overall survival (OS) rate were 68.7%±4.5% and 70.7%±4.3%, respectively. There were no significant differences in long-term efficacy observed among patients with different disease statuses before infusion (4-year OS: MRD re-emergence vs. R/R B-ALL, 70.6%±6.6% vs. 66.5%±6.1%, p=0.755; 4-year LFS: MRD re-emergence vs. R/R B-ALL, 67.3%±7.0% vs. 63.8%±6.2%, p=0.704). R/R B-ALL patients bridging to transplantation after CAR-T treatment had a superior OS and LFS compared to those who did not. However, for MRD re-emergent patients, there was no significant difference in OS and LFS, regardless of whether they underwent hematopoietic stem cell transplantation or not.Conclusion CD19 CAR-T therapy effectively and safely cures both R/R B-ALL and MRD re-emergent patients.

01 May 2024·British Journal of Haematology

The role of chimeric antigen receptor T cells targeting more than one antigen in the treatment of B‐cell malignancies

Review

Author: Guedan, Sònia ; Martínez‐Cibrián, Núria ; Ortiz‐Maldonado, Valentín ; Alserawan, Leticia ; Bachiller, Mireia ; Delgado, Julio ; Brillembourg, Helena

SummarySeveral products containing chimeric antigen receptor T cells targeting CD19 (CART19) have been approved for the treatment of patients with relapsed/refractory non‐Hodgkin's lymphoma (NHL) and acute lymphoblastic leukaemia (ALL). Despite very impressive response rates, a significant percentage of patients experience disease relapse and die of progressive disease. A major cause of CART19 failure is loss or downregulation of CD19 expression in tumour cells, which has prompted a myriad of novel strategies aimed at targeting more than one antigen (e.g. CD19 and CD20 or CD22). Dual targeting can the accomplished through co‐administration of two separate products, co‐transduction with two different vectors, bicistronic cassettes or tandem receptors. In this manuscript, we review the pros and cons of each strategy and the clinical results obtained so far.

100 Deals associated with CAR-T-19(Immunotech Biopharm)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent B Acute Lymphoblastic Leukemia	Phase 2	CN	Beijing Yongtai Ruike Biotechnology Co. Ltd.	31 Dec 2023
Refractory B Acute Lymphoblastic Leukemia	Phase 2	CN	Beijing Yongtai Ruike Biotechnology Co. Ltd.	31 Dec 2023
CD19-positive B-cell acute lymphoblastic leukemia	Phase 2	CN	Beijing Yongtai Ruike Biotechnology Co. Ltd.	28 Dec 2023
Lymphoma	Phase 1	CN	Immunotech Biopharm Ltd	22 Jun 2022
B-Cell Leukemia	Phase 1	CN	Immunotech Biopharm Ltd	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2023	Not Applicable	-	43	CART19	qqxfggycof(elkgshkcph) = hkzrbqduka ragnvyovdk (adqzzvvgyc )	-	10 Dec 2023
				CART22	qqxfggycof(elkgshkcph) = kdabesncox ragnvyovdk (adqzzvvgyc )