Delving into the Latest Updates on Velinotamig with Synapse

Overview

Basic Info

Drug Type

Bispecific T-cell Engager (BiTE)

Synonyms

Target

BCMA x CD3

Mechanism

BCMA modulators(B-cell maturation protein modulators), CD3 modulators(T cell surface glycoprotein CD3 modulators)

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [1]

Active Indication

Multiple Myeloma

Inactive Indication-

Originator Organization

Zhixiang (Shanghai) Medical Technology Co., Ltd.

Chongqing Genrix Biopharmaceutical Co., Ltd.

Active Organization

Chongqing Genrix Biopharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationBreakthrough Therapy (CN)

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Structure/Sequence

Sequence Code 1116789870H

Source: *****

Sequence Code 565352114H

Source: *****

Sequence Code 1116789871L

Source: *****

All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.

Start Date26 Aug 2024

Sponsor / Collaborator

Zhixiang (Shanghai) Medical Technology Co., Ltd.

CTR20242576

/ RecruitingPhase 2

GR1803注射液在复发性/难治性多发性骨髓瘤患者中有效性、安全性、药代动力学和免疫原性的单臂、开放、多中心II期临床试验

[Translation] A single-arm, open-label, multicenter Phase II clinical trial of the efficacy, safety, pharmacokinetics, and immunogenicity of GR1803 injection in patients with relapsed/refractory multiple myeloma

主要目的评价GR1803注射液在多发性骨髓瘤患者中有效性特征；次要目的评价GR1803注射液在多发性骨髓瘤患者中安全性特征；评价GR1803注射液在多发性骨髓瘤患者中药代动力学特征；评价GR1803注射液在多发性骨髓瘤患者中免疫原性特征；探索目的探索GR1803血药浓度与药效动力学、安全性和有效性的关系；评价GR1803注射液对受试者报告的症状和功能的影响。

[Translation]

Primary purpose To evaluate the efficacy characteristics of GR1803 injection in patients with multiple myeloma; Secondary purpose To evaluate the safety characteristics of GR1803 injection in patients with multiple myeloma; To evaluate the pharmacokinetic characteristics of GR1803 injection in patients with multiple myeloma; To evaluate the immunogenicity characteristics of GR1803 injection in patients with multiple myeloma; Exploratory purpose To explore the relationship between GR1803 blood concentration and pharmacodynamics, safety and efficacy; To evaluate the effect of GR1803 injection on the symptoms and functions reported by subjects.

Start Date11 Aug 2024

Sponsor / Collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd.

[+1]

CTR20220402

/ RecruitingPhase 1

GR1803注射液在复发/难治的多发性骨髓瘤患者中单次、多次给药的安全性、药代动力学、免疫原性和初步疗效的I期临床研究

[Translation] Phase I clinical study on the safety, pharmacokinetics, immunogenicity and preliminary efficacy of single and multiple doses of GR1803 injection in patients with relapsed/refractory multiple myeloma

评价GR1803注射液在多发性骨髓瘤患者中安全性、耐受性、最大耐受剂量（MTD）和2期推荐剂量（RP2D）。评价GR1803注射液在多发性骨髓瘤患者中的药代动力学特征、免疫原性及初步疗效。

[Translation]

To evaluate the safety, tolerability, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of GR1803 injection in patients with multiple myeloma. To evaluate the pharmacokinetic characteristics, immunogenicity and preliminary efficacy of GR1803 injection in patients with multiple myeloma.

Start Date09 May 2022

Sponsor / Collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Velinotamig

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100 Translational Medicine associated with Velinotamig

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100 Patents (Medical) associated with Velinotamig

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100 Deals associated with Velinotamig

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Myeloma	Phase 2	CN	Chongqing Genrix Biopharmaceutical Co., Ltd.	11 Aug 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20220402 (EHA 12024 \| EHA 22024) Manual	Phase 1	Relapse multiple myeloma	50	GR1803 (All pts)	(xvlsxmklen) = prighfwzqa utsfilyoeq (ziygcriycc ) View more	Positive	14 May 2024
				GR1803 (180ug/kg)	(ovfuojhxru) = ivhsrkaiuy zfupezocly (pokkxclouo )