Delving into the Latest Updates on RJK-RT2831 with Synapse

Overview

Basic Info

Drug Type

Bispecific antibody

Synonyms

a humanized IgG1 bispecific antibody targeting CD33 and CD123 (RegeneCore), RJK-RT2831, RT 2831

+ [2]

Target

CD123 x CD33

Action

inhibitors

Mechanism

CD123 inhibitors(Interleukin-3 receptor subunit alpha inhibitors), CD33 inhibitors(Myeloid cell surface antigen CD33 inhibitors)

Therapeutic Areas

NeoplasmsHemic and Lymphatic DiseasesOther Diseases

Active Indication

Refractory acute myeloid leukemiaAcute Myeloid LeukemiaAcute Promyelocytic Leukemia+ [1]

Inactive Indication-

Originator Organization

RegeneCore Biotech Co., Ltd

Active Organization

RegeneCore Biotech Co., Ltd

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

RegulationOrphan Drug (United States)

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1.主要目的：评估 RJK-RT2831 在恶性血液肿瘤受试者中的安全性、耐受性和最大耐受剂量。确定 RJK-RT2831 治疗恶性血液肿瘤受试者的扩展期推荐剂量。 2.次要目的：评估 RJK-RT2831 在恶性血液肿瘤受试者中单、多次给药的药代动力学特征。评估 RJK-RT2831 在恶性血液肿瘤受试者中的初步抗肿瘤活性。评估 RJK-RT2831 在恶性血液肿瘤受试者中的免疫原性。

[Translation]

1. Primary objectives: To evaluate the safety, tolerability and maximum tolerated dose of RJK-RT2831 in subjects with hematological malignancies. To determine the recommended dose of RJK-RT2831 for the extension phase of the treatment of subjects with hematological malignancies. 2. Secondary objectives: To evaluate the pharmacokinetic characteristics of single and multiple administrations of RJK-RT2831 in subjects with hematological malignancies. To evaluate the preliminary anti-tumor activity of RJK-RT2831 in subjects with hematological malignancies. To evaluate the immunogenicity of RJK-RT2831 in subjects with hematological malignancies.

Start Date19 Mar 2025

Sponsor / Collaborator

RegeneCore Biotech Co., Ltd

100 Clinical Results associated with RJK-RT2831

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100 Translational Medicine associated with RJK-RT2831

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100 Patents (Medical) associated with RJK-RT2831

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100 Deals associated with RJK-RT2831

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory acute myeloid leukemia	Phase 1	China	RegeneCore Biotech Co., Ltd	25 Mar 2025
Acute Myeloid Leukemia	Phase 1	China	RegeneCore Biotech Co., Ltd	19 Mar 2025
Acute Promyelocytic Leukemia	Phase 1	China	RegeneCore Biotech Co., Ltd	19 Mar 2025
Hematologic Neoplasms	IND Approval	United States	RegeneCore Biotech Co., Ltd	25 Jul 2024

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Clinical Result

Indication

Phase

Evaluation

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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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