Delving into the Latest Updates on HR-001 with Synapse

Overview

Basic Info

Drug Type

Autologous CAR-T

Synonyms

CD19-41BB-tEGFR, CD19-CART (Hrain Biotechnology), CD19-CD28-tEGFR

+ [4]

Target

CD19

Mechanism

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

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases

Active Indication

B-cell lymphoma recurrentB-cell lymphoma refractoryCD19-positive B-cell acute lymphoblastic leukemia

Inactive Indication

CD19 positive Acute Lymphoblastic LeukemiaCD19 Positive B-Cell LeukemiaCD19 positive Diffuse Large B-Cell Lymphoma+ [4]

Originator Organization

Hrain Biotechnology Co., Ltd.Startup

Active Organization

Hrain Biotechnology Co., Ltd.StartupShanghai Hengrun Dasheng Biopharmaceutical Co., Ltd.

Inactive Organization

Zhongshan Hospital Fudan University

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationPriority Review (CN)

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主要研究目的：评价抗人CD19 T细胞注射液用于治疗复发/难治性B细胞非霍奇金淋巴瘤受试者的的有效性；次要研究目的：评价抗人CD19 T细胞注射液用于治疗复发/难治性B细胞非霍奇金淋巴瘤受试者的安全性、药代动力学和药效动力学。

[Translation]

Primary study objective: To evaluate the effectiveness of anti-human CD19 T cell injection in the treatment of relapsed/refractory B-cell non-Hodgkin's lymphoma subjects; Secondary study objective: To evaluate the safety, pharmacokinetics and pharmacodynamics of anti-human CD19 T cell injection in the treatment of relapsed/refractory B-cell non-Hodgkin's lymphoma subjects.

Start Date18 Oct 2021

Sponsor / Collaborator

Hrain Biotechnology Co., Ltd.Startup

NCT03798509 / Unknown statusPhase 1

A Phase I Clinical Trial to Evaluate the Safety and Tolerability of Human CD19 Targeted T Cells Injection for Subjects With Relapsed and Refractory CD19-positive B-cell Acute Lymphoblastic Leukemia

To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive B-cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.

Start Date13 Mar 2019

Sponsor / Collaborator

Hrain Biotechnology Co., Ltd.Startup

[+1]

NCT03720457 / Unknown statusPhase 1

A Phase I Clinical Trial of Human CD19 Targeted T Cells Injection for Subjects With Relapsed and Refractory CD19-positive Diffuse Large B-cell Lymphoma and Follicular Lymphoma

To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive diffuse large B-cell lymphoma and follicular lymphoma. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.

Start Date13 Nov 2018

Sponsor / Collaborator

Hrain Biotechnology Co., Ltd.Startup

[+1]

100 Clinical Results associated with HR-001

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100 Translational Medicine associated with HR-001

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100 Patents (Medical) associated with HR-001

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3

Literatures (Medical) associated with HR-001

01 Jan 1987·ToxiconQ3 · MEDICINE

Purification of three antihemorrhagic factors from the serum of a mongoose (Herpestes edwardsii)

Q3 · MEDICINE

Article

Author: Takao Kamura ; Yasuhiro Tomihara ; Kazuo Yonaha ; Seizen Toyama ; Masatoshi Nozaki ; Masanobu Yamakawa

Three antihemorrhagic factors (AHF-1, AHF-2 and AHF-3) were purified from the serum of H. edwardsii, a mongoose, by a combination of gel filtration on a Sephadex G-200 column and high performance liquid chromatography with a TSK gel DEAE-5PW column. Each of the purified antihemorrhagic factors showed a single band on polyacrylamide gel disc electrophoresis. The three antihemorrhagic factors inhibited the hemorrhagic activity of HR 1 and HR 2, the hemorrhagic principles from the snake venom of Trimeresurus flavoviridis Okinawa. AHF-1, AHF-2 and AHF-3 were stable at temperatures from 0 degrees to 60 degrees C and at pH values between 2.0 and 11.0. The same molecular weight (65,000) was obtained for the three antihemorrhagic factors. No precipitin lines were found for the purified antihemorrhagic factors with the venom of T. flavoviridis Okinawa and its hemorrhagic principles, HR 1 and HR 2.

01 Jan 1965·Japanese Journal of Medical Science and Biology

STANDARDIZATION OF ANTIVENINE II. A METHOD FOR DETERMINATION OF ANTIHEMORRHAGIC POTENCY OF HABU ANTIVENINE IN THE PRESENCE OF TWO HEMORRHAGIC PRINCIPLES AND THEIR ANTIBODIES

Article

Author: Satoru Kondo ; Hisashi Kondo ; Ryosuke Murata ; Seiji Sadahiro ; Akira Ohsaka ; Kiyosumi Yamauchi

cf. CA 63, 13843b.Since 2 immunologically specific hemorrhagic principles are present in the Habu venin, 2 distinct antibodies must be in the antivenin serums.The 2 venin fractions (HR-1 and HR-2) were separated by zone electrophoresis and used for the assay of the corresponding antivenins.HR-1 and HR-2 were similar in their hemorrhagic activity on rabbit skin.The ratio of anti-HR-1 and anti-HR-2 differed in different preparations of antivenin.Larger amounts of antivenin were required to neutralize HR-2 than HR-1.An antihemorrhagic unit is defined as the amount of specific antibody required to neutralize 100 min. hemorrhagic doses of venom when injected intracutaneously in the backs of rabbits.The hemorrhagic area was measured on the visceral side of the skin.The effective dose of antivenin is the quantity which when mixed with a given dose of toxin causes a hemorrhagic spot with an average diameter of 10 mm.This is determined by the statistical analysis of the dose-response curve.The anti-hemorrhagic activities of the antivenins were determined using both HR-1 and HR-2 fractions, and the antihemorrhagic activity expressed in terms of both fractions.

MedicineQ4 · MEDICINE

Diagnostic difficulties of AH1N1 influenza infection in children with acute lymphoblastic leukemia

Q4 · MEDICINE

ArticleOA

Author: Drabko, Katarzyna ; Lejman, Monika ; Zawitkowska, Joanna ; Zaucha-Prażmo, Agnieszka

AbstractIntroduction:Children with acute lymphoblastic leukemia (ALL) are at a risk of developing influenza-related complications. Approximately 10% of influenza-infected children with ALL or other types of cancer need intensive care, and 5% of them eventually die.Patients’ concerns:We report 2 children with ALL and the swine-origin influenza A virus infection. Diagnosing influenza in them was a challenge. Medical records of these children were reviewed for demographic, clinical, and laboratory data. Patients were hospitalized in the Department of Pediatric Hematology, Oncology, and Transplantology of the Medical University of Lublin, Poland. Case 1 involved a 2-year-old girl who, according to acute lymphoblastic leukemia intercontinental Berlin-Frankfürt-Münster protocol 2009, started chemotherapy in July 2015. She was categorized in the intermediate risk group and received the induction and consolidation phase of the therapy without severe complications. The reinduction therapy was administered in the outpatient department till the 15th day. On the 20th day of this phase, she was admitted to our department with fever, mucositis, tachypnea, abdominal pain, and diarrhea. In September 2009, a 14-year-old boy (case 2) who, according to acute lymphoblastic leukemia intercontinental Berlin-Frankfürt-Münster protocol 2002, was categorized in the high-risk (HR) group, received the induction (Protocol I) phase of therapy without severe complications. On the 7th day of the HR-1 course, he manifested fever and strong, tiring cough, followed by strong mucositis. Chemotherapy had to be interrupted in both children.Diagnosis:Respiratory viral infections, causing pneumonia, occurred in both patients during anticancer treatment. Initially, the real-time polymerase chain reaction test for the swine-origin influenza A was negative in both patients, which delayed the diagnosis. Additionally, bacterial, and fungal complications were also observed.Interventions:Both patients received oseltamivir twice a day, a broad-spectrum antibiotic, antifungal drug, and granulocyte colony growth factor.Outcomes:The disease progressed quickly, and our patients subsequently died.Conclusion:We speculated that early antiviral treatment can help in the better management of patients in the HR group. It is also important to minimize influenza morbidity and mortality by vaccinating family members, using empiric therapy, providing immediate antiviral therapy, and educating parents about hygiene measures.

100 Deals associated with HR-001

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
B-cell lymphoma recurrent	NDA/BLA	CN	Hrain Biotechnology Co., Ltd.Startup	14 Dec 2023
B-cell lymphoma refractory	NDA/BLA	CN	Shanghai Hengrun Dasheng Biopharmaceutical Co., Ltd.	14 Dec 2023
CD19-positive B-cell acute lymphoblastic leukemia	Phase 1	CN	Hrain Biotechnology Co., Ltd.Startup	12 Nov 2018
CD19 positive Diffuse Large B-Cell Lymphoma	Preclinical	CN	Zhongshan Hospital Fudan University	13 Nov 2018
CD19 Positive Lymphoma	Preclinical	CN	Hrain Biotechnology Co., Ltd.Startup	13 Nov 2018
CD19 Positive Lymphoma	Preclinical	CN	Zhongshan Hospital Fudan University	13 Nov 2018
Diffuse large B-cell lymphoma recurrent	Preclinical	CN	Hrain Biotechnology Co., Ltd.Startup	13 Nov 2018
Follicular Lymphoma	Preclinical	CN	Hrain Biotechnology Co., Ltd.Startup	13 Nov 2018
Follicular Lymphoma	Preclinical	CN	Zhongshan Hospital Fudan University	13 Nov 2018
Diffuse large B-cell lymphoma refractory	Discovery	CN	Hrain Biotechnology Co., Ltd.Startup	13 Nov 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


HRAIN01-NHL01-II (AACR2024) Manual	Phase 2	Non-Hodgkin Lymphoma	81	HR001	(uuggvjtnyq) = phhyvhxvxy fxuxtimumc (nvowyfszrl, 22.2 - 43.4) View more	Positive	05 Apr 2024
NCT03110640 (Pubmed \| Oncol Lett) Manual	Phase 1	CD19 positive Acute Lymphoblastic Leukemia CD19 Positive	9	CD19-CAR T-cell therapy	(tkncuexhel) = the incidence of acute graft-versus-host disease or extensive chronic graft-versus-host disease did not increase hivosafzik (fqbxmekejg )	Positive	01 Oct 2020