Chimeric antigen receptor T cells (CAR-T cells) has been recognized a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of third-generation anti-CD19 CAR T-cells (CD19-CAR-T2 Cells) in patients with CD19+ relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell Non Hodgkin Lymphoma (B-NHL).

Start Date01 May 2020

Sponsor / Collaborator

Nanfang Hospital

NCT02822326 / Unknown statusPhase 1IIT

CD19-CAR-T2 Cells for Relapse/Refractory CD19 Positive Acute Leukemia-a Phase I Trial

The purpose of this study is to evaluate the safety and efficacy of chimeric antigen receptor 19 (CD19-CAR-T2 Cells) infusions in patients with chemotherapy resistant or refractory CD19+ acute Leukemia.

Start Date01 Jan 2016

Sponsor / Collaborator

Guangdong General Hospital

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100 Clinical Results associated with CD19-CAR-T2 Cells(Guangdong Zhaotai InVivo Biomedicine)

100 Translational Medicine associated with CD19-CAR-T2 Cells(Guangdong Zhaotai InVivo Biomedicine)

100 Patents (Medical) associated with CD19-CAR-T2 Cells(Guangdong Zhaotai InVivo Biomedicine)

Literatures (Medical) associated with CD19-CAR-T2 Cells(Guangdong Zhaotai InVivo Biomedicine)

01 Sep 2020·Journal for ImmunoTherapy of CancerQ2 · MEDICINE

Impact of cytokine release syndrome on cardiac function following CD19 CAR-T cell therapy in children and young adults with hematological malignancies

Q2 · MEDICINE

ArticleOA

Author: Sidenko, Stanislav ; Shalabi, Haneen ; Yates, Bonnie ; Wiley, Brandon ; Shah, Nirali N ; Kulshreshtha, Amita ; Cohen, Julia W ; Sachdev, Vandana ; Delbrook, Cindy ; Mackall, Crystal ; Lee, Daniel W ; Rosing, Doug R

BackgroundChimeric antigen receptor (CAR) T-cell-associated cytokine release syndrome (CRS) may present with tachycardia, hemodynamic instability and reduced cardiac function. Pediatric CAR studies examining cardiac toxicity are limited.MethodsWe report on cardiac toxicity observed in children and young adults with hematologic malignancies enrolled in a CD19-28ζ CAR T-cell phase I trial (NCT01593696). All patients had a formal baseline echocardiogram. Real-time studies included echocardiograms on intensive care unit (ICU) transfer, and serial troponin and pro-B-type natriuretic peptide (pro-BNP) in the select patients.ResultsFrom July 2012 to March 2016, 52 patients, with a median age of 13.4 years (range 4.2–30.3) were treated. CRS developed in 37/52 (71%), which was grade 3–4 CRS in nine patients (17%). The median prior anthracycline exposure was 205 mg/m2 (range 70–620 mg/m2) in doxorubicin equivalents. The median baseline left ventricle ejection fraction (LVEF) and baseline LV global longitudinal strain (GLS) were 60% (range 50%–70%) and 16.8% (range 14.1%–23.5%, n=37) respectively. The majority, 78% (29/37), of patients had a reduced GLS <19% at baseline, and 6% (3/52) of patients had baseline LVEF <53%. ICU transfers occurred in 21 patients, with nine requiring vasoactive hemodynamic support and three necessitating >1 vasopressor. Six (12%) patients developed cardiac dysfunction (defined by >10% absolute decrease in LVEF or new-onset grade 2 or higher LV dysfunction, per CTCAE v4), among whom 4 had grade 3–4 CRS. Troponin elevations were seen in 4 of 13 patients, all of whom had low LVEF. Pro-BNP was elevated from baseline in 6/7 patients at the onset of CRS, with higher levels correlating with more severe CRS. Cardiac dysfunction fully resolved in all but two patients by day 28 post-CAR.ConclusionCardiac toxicity related to CD19-28ζ CAR T-cell-associated CRS was generally reversible by day 28 postinfusion. Implementation of more frequent monitoring with formal echocardiograms incorporating systemic analysis of changes in GLS, and cardiac biomarkers (troponin and proBNP) may help to earlier identify those patients at highest risk of severe cardiac systolic dysfunction, facilitating earlier interventions for CRS to potentially mitigate acute cardiac toxicity.

100 Deals associated with CD19-CAR-T2 Cells(Guangdong Zhaotai InVivo Biomedicine)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
B-Cell Lymphoma	Phase 2	CN	Nanfang Hospital	01 May 2020
CD19 Positive B-Cell Leukemia	Phase 2	CN	Nanfang Hospital	01 May 2020
Leukemia	Discovery	CN	Guangdong Zhaotai InVivo Biomedicine Co. Ltd.	01 Jan 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2023	Phase 2	Philadelphia positive acute lymphocytic leukaemia First line	18	Dasatinib + CD19 CAR-T cell therapy	(hfaazodhbx) = eihurogbyt ezogjmkycq (jrfestmlbs )	Positive	11 Dec 2023
ASH2023	Phase 2		18	Dasatinib + CD22 CAR-T cell therapy	(hfaazodhbx) = dkopeewkfz ezogjmkycq (jrfestmlbs )	Positive	11 Dec 2023
NCT02822326 (Pubmed \| J Hematol Oncol) Manual	Phase 1	Acute Lymphoblastic Leukemia	3	1928zT2 T cells	(spiqhfoiia) = qbpthrpfak xyvmrswysd (yiwqkhdpib ) View more	Positive	20 Feb 2018

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