[Translation] A multicenter, open-label, dose-escalation and cohort expansion Phase I/II clinical study of the safety, pharmacokinetics and antitumor efficacy of MH048 in patients with relapsed/refractory B-cell malignancies

主要目的：评价 MH048 在复发/难治性 B-NHL 患者中的安全性及耐受性，确定 MH048 的最大耐受剂量（MTD）和推荐Ⅱ期临床剂量（RP2D）次要目的：研究 MH048 及其活性代谢产物 M3 在复发/难治性 B-NHL 患者中的药代动力学特性。获得 MH048 在复发/难治性慢 B-NHL 患者中的抗肿瘤活性的初步数据。

[Translation]

Primary objective: To evaluate the safety and tolerability of MH048 in patients with relapsed/refractory B-NHL, and to determine the maximum tolerated dose (MTD) and recommended phase II clinical dose (RP2D) of MH048. Secondary objective: To study the pharmacokinetic properties of MH048 and its active metabolite M3 in patients with relapsed/refractory B-NHL. To obtain preliminary data on the anti-tumor activity of MH048 in patients with relapsed/refractory chronic B-NHL.

Start Date07 Dec 2021

Sponsor / Collaborator

Minghui Pharmaceutical (Shanghai) Co., Ltd.

CTR20202457 / RecruitingPhase 1

MH048 用于复发/难治性 B 细胞恶性肿瘤患者的安全性、药代动力学以及抗肿瘤药效的多中心、开放标签、剂量递增及队列扩展 Ⅰ/Ⅱ 期临床研究

主要目的：评价 MH048 在复发/难治性 B-NHL 患者中的安全性及耐受性确定 MH048 的最大耐受剂量（MTD），并基于方案定义的剂量限制性毒性次要目的：研究 MH048 及其活性代谢产物 M3 在复发/难治性 B-NHL 患者中的药代动力学特性。获得 MH048 在复发/难治性慢 B-NHL 患者中的抗肿瘤活性的初步数据。

[Translation]

Primary objective: To evaluate the safety and tolerability of MH048 in patients with relapsed/refractory B-NHL. To determine the maximum tolerated dose (MTD) of MH048 and the dose-limiting toxicity defined by the protocol. Secondary objective: To study the pharmacokinetic properties of MH048 and its active metabolite M3 in patients with relapsed/refractory B-NHL. To obtain preliminary data on the anti-tumor activity of MH048 in patients with relapsed/refractory chronic B-NHL.

Start Date07 Jan 2021

Sponsor / Collaborator

Minghui Pharmaceutical (Shanghai) Co., Ltd.

NCT04689308 / Unknown statusPhase 1

A Phase 1, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Antitumor Activity of MH048 in Subjects With Selected Relapsed/Refractory B-cell Malignancies

This is a Phase 1 study of MH048 in patients with selected Relapsed/Refractory B-cell Malignancies.

Start Date07 Jan 2021

Sponsor / Collaborator

Minghui Pharmaceutical (Hangzhou) Co., Ltd.Startup

100 Clinical Results associated with MH-048

100 Translational Medicine associated with MH-048

100 Patents (Medical) associated with MH-048

Literatures (Medical) associated with MH-048

01 Jan 2005·Medicina (Kaunas, Lithuania)Q4 · MEDICINE

New xanthone derivatives as potent anti-inflammatory agents.

Q4 · MEDICINE

ArticleOA

Author: Librowski, Tadeusz ; Czekaj, Teresa ; Marona, Henryk ; Czarnecki, Ryszard

A series of novel xanthone derivatives were synthesized as potential anti-inflammatory compounds. The compounds were examined for anti-inflammatory and analgesic properties. Aspirin and ketoprofen were used as reference compounds.MATERIAL AND METHODSAcute inflammation was induced by subplantar injection of 0.1 ml of 1% carrageenan solution to the right rat paw, 1 hour after oral administration of the investigated compound. The development of paw edema was measured plethysmographically. Pain threshold in the hind paw of rat affected by inflammation was measured using an analgesimeter 4 hours after oral administration of the compounds. Mean pain thresholds were calculated for treated and control groups and the percent change from control was determined. Thus we observed irritation of gastric mucosa after use of compounds, which showed significant anti-inflammatory activity. The mucosa of the glandular part of the stomach was inspected using a binocular microscope.RESULTSThe preliminary investigation of the anti-inflammatory activity of the novel xanthone derivatives showed uneven anti-inflammatory and analgesic activity. The highest anti-inflammatory and analgesic activity was provided by compound MH-44. The compounds MH-41, MH-43 and MH-48 potentiated the carrageenan edema and lowered the threshold pain in comparison with control. Side effects of the active compound were examined on gastric mucosa and stomach and none of the active compounds showed significant side effects compared with nonsteroidal anti-inflammatory drugs.CONCLUSIONSNone of the active compounds showed significant side effects compared with nonsteroidal anti-inflammatory drugs.

100 Deals associated with MH-048

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
B-Cell Malignant Neoplasm	Phase 2	CN	Minghui Pharmaceutical (Shanghai) Co., Ltd.	07 Dec 2021
Neoplasms	Phase 1	CN	Minghui Pharmaceutical (Hangzhou) Co., Ltd.Startup	07 Jan 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04689308 (ASCO2022) Manual	Phase 1	Chronic Lymphocytic Leukemia	12	MH048	(iocipqqxli) = Drug-related grade 3 TEAEs included platelet count decrease, neutrophil count decrease, lipase increase, and hypertension (one patient for each). gbfvdcbsgp (sbgqfifgfy ) View more	Positive	02 Jun 2022

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