Delving into the Latest Updates on MBS314 with Synapse

Overview

Basic Info

Drug Type

Trispecific T-cell engager (TriTE)

Synonyms

Target

Mechanism

BCMA inhibitors(B-cell maturation protein inhibitors), CD3 inhibitors(T cell surface glycoprotein CD3 inhibitors), GPRC5D inhibitors(G-protein coupled receptor family C group 5member D inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [2]

Active Indication

Plasma cell myeloma refractoryRelapse multiple myelomaMultiple Myeloma

Inactive Indication-

Originator Organization

Beijing Mabworks Biotech Co., Ltd.

Active Organization

Beijing Mabworks Biotech Co., Ltd.

Kyinno Biotechnology Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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This is a Phase I/Ⅱ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel asymmetric trivalent tri-specific humanized antibody, MBS314, administered by intravenous (IV) infusion in participants with relapsed or refractory multiple myeloma. This entry-to-human study is divided in 2 parts: a dose escalation part (Phase Ⅰa) and an expansion part (Phase Ⅰb/Ⅱ).

Start Date22 Feb 2024

Sponsor / Collaborator

Beijing Mabworks Biotech Co., Ltd.

CTR20240206 / RecruitingPhase 1/2

一项评价MBS314注射液治疗复发/难治性多发性骨髓瘤的安全性、耐受性、药代动力学、药效动力学特征和有效性的I/Ⅱ期临床研究。

[Translation] A Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic characteristics and efficacy of MBS314 injection in the treatment of relapsed/refractory multiple myeloma.

第一阶段：主要研究目标：评估MBS314在复发/难治性多发性骨髓瘤（R/RMM）患者中的安全性和耐受性,并观察MBS314的剂量限制性毒性（DLT），确定在人体的最大耐受剂量（MTD）（如有）或最佳生物剂量（OBD），为后续临床研究确定推荐的Ⅱ期剂量（RP2D）。第二阶段：主要研究目标：评估有效性。

[Translation]

Phase I: Main research objectives: To evaluate the safety and tolerability of MBS314 in patients with relapsed/refractory multiple myeloma (R/RMM), and to observe the dose-limiting toxicity (DLT) of MBS314, to determine the maximum tolerated dose (MTD) (if any) or optimal biological dose (OBD) in humans, and to determine the recommended Phase II dose (RP2D) for subsequent clinical studies. Phase II: Main research objectives: To evaluate effectiveness.

Start Date29 Jan 2024

Sponsor / Collaborator

Kyinno Biotechnology Co., Ltd.

[+1]

100 Clinical Results associated with MBS314

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100 Translational Medicine associated with MBS314

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100 Patents (Medical) associated with MBS314

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100 Deals associated with MBS314

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Plasma cell myeloma refractory	Phase 2	CN	Beijing Mabworks Biotech Co., Ltd.	22 Feb 2024
Relapse multiple myeloma	Phase 2	CN	Beijing Mabworks Biotech Co., Ltd.	22 Feb 2024
Multiple Myeloma	Phase 2	CN	Kyinno Biotechnology Co., Ltd.	29 Jan 2024