[Translation] A Phase I, open-label, multicenter, first-in-human, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary efficacy of MRG001 in patients with CD20-positive relapsed or refractory B-cell non-Hodgkin lymphoma (NHL)

确定MRG001在复发或难治的B细胞非霍奇金淋巴瘤患者中的安全性和耐受性，并初步评估抗肿瘤活性。同时评估MRG001的药代动力学特征，及患者对MRG001的免疫原性。

[Translation]

Determine the safety and tolerability of MRG001 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma and preliminarily evaluate its anti-tumor activity. Also evaluate the pharmacokinetic characteristics of MRG001 and the immunogenicity of MRG001 in patients.

Start Date25 Jun 2019

Sponsor / Collaborator

Shanghai Miracogen, Inc.

NCT05155839 / Unknown statusPhase 1

An Open-label, Multicenter, First-in-human, Phase I Dose-escalation and Expansion Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of MRG001 in Patients With CD20-positive Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL)

This study consists of two parts. Phase Ia is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG001. Phase Ib is a dose expansion study to assess the preliminary efficacy of MRG001 in patients with CD20-positive relapsed or refractory B-cell NHL at the confirmed RP2D. The safety, tolerability, pharmacokinetic (PK) and immunogenicity of MRG001 will be evaluated in both parts.

Start Date25 Jun 2019

Sponsor / Collaborator

Shanghai Miracogen, Inc.

100 Clinical Results associated with MRG-001

100 Translational Medicine associated with MRG-001

100 Patents (Medical) associated with MRG-001

Literatures (Medical) associated with MRG-001

01 Sep 2023·Cell Reports Medicine

A phase I, first-in-human study to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of MRG-001 in healthy subjects

Article

Author: Wesson, Russell N ; Sun, Zhaoli ; Chapman, Bart ; Ahmadi, Ali R ; Cameron, Andrew M ; Burdick, James F ; Reynolds, Laurie ; Atiee, George ; Sun, John

Preclinical studies demonstrate that pharmacological mobilization and recruitment of endogenous bone marrow stem cells and immunoregulatory cells by a fixed-dose drug combination (MRG-001) improves wound healing, promotes tissue regeneration, and prevents allograft rejection. In this phase I, first-in-human study, three cohorts receive subcutaneous MRG-001 or placebo, every other day for 5 days. The primary outcome is safety and tolerability of MRG-001. Fourteen subjects received MRG-001 and seven received a placebo. MRG-001 is safe over the selected dose range. There are no clinically significant laboratory changes. The intermediate dose group demonstrates the most significant white blood cell, stem cell, and immunoregulatory cell mobilization. PBMC RNA sequencing and gene set enrichment analysis reveal 31 down-regulated pathways in the intermediate MRG-001 dose group compared with no changes in the placebo group. MRG-001 is safe across all dose ranges. MRG-001 may be a clinically useful therapy for immunoregulation and tissue regeneration (ClinicalTrials.gov: NCT04646603).

01 Aug 2011·Applied Microbiology and BiotechnologyQ3 · ENGINEERING & TECHNOLOGY

Stereospecific microbial production of isoflavanones from isoflavones and isoflavone glucosides

Q3 · ENGINEERING & TECHNOLOGY

Article

Author: Hye-Yeon Park ; Jaehong Han ; Mihyang Kim

A Gram-negative anaerobic microorganism, MRG-1, isolated from human intestine showed high activities of deglycosylation and reduction of daidzin, based on rapid TLC analysis. A rod-shaped strain MRG-1 was identified as a new species showing 91.0% homology to Coprobacillus species, based on 16S rRNA sequence analysis. The strain MRG-1 showed β-glucosidase activity toward daidzin and genistin, and daidzein and genistein were produced, respectively. However, the strain MRG-1 did not react with flavone glycosides, flavanone glycosides, and isoflavone C-glucoside. Besides, MRG-1 showed stereoselective reductase activity to isoflavone, daidzein, genistein, 7-hydroxyisoflavone, and formononetin, resulting in the formation of corresponding R-isoflavanone enantiomers. The new isoflavanones of 7-hydroxyisoflavanone and dihydroformononetin were characterized by NMR, and the absolute configurations of the enantiomers were determined with CD spectroscopy. The kinetic study of the anaerobic biotransformation showed both activities were exceptionally fast compared to the reported conversion by other anaerobic bacteria.

100 Deals associated with MRG-001

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
CD20 Positive B-Cell Non-Hodgkin Lymphoma	Phase 1	CN	Shanghai Miracogen, Inc.	25 Jun 2019
Non-Hodgkin's lymphoma refractory	Phase 1	CN	Shanghai Miracogen, Inc.	25 Jun 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2023	Phase 1	Diffuse large B-cell lymphoma recurrent	35	MRG001 1.8 mg/kg	(czefwfyuhf) = ubkdhgmdae jmxkqcwsqr (tinibwvzzp, 22.2 - 56.4) View more	-	10 Dec 2023

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