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RECRUITING
NCT07124936
PHASE1/PHASE2

A Study of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma

Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this phase 1b/2 study is to evaluate the safety, tolerability, and antitumor activity of HDM2005 in combination with standard of care in participants with diffuse large B-cell lymphoma. This study will include two arms: Cohort A (HDM2005 + R-GemOx) will enroll participants with relapsed/refractory DLBCL. Cohort B (HDM2005 + R-CHP) will enroll participants with untreated DLBCL. The study will consist of two parts: dose-escalation part and dose-expansion part.

Official title: A Phase 1b/2 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

97

Start Date

2025-07-30

Completion Date

2029-10-25

Last Updated

2025-08-15

Healthy Volunteers

No

Interventions

DRUG

HDM2005

HDM2005 will be administered as an intravenous injection.

DRUG

Rituximab or Rituximab biosimilar

Rituximab or Rituximab biosimilar will be administered as an intravenous injection.

DRUG

Gemcitabine

Gemcitabine will be administered as an intravenous injection.

DRUG

Oxaliplatin

Oxaliplatin will be administered as an intravenous injection.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered as an intravenous injection.

DRUG

Doxorubicin

Doxorubicin will be administered as an intravenous injection.

DRUG

Prednisone

Prednisone will be administered orally.

Locations (21)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, China

Affiliated Tumor Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

HunanCancer Hospital

Changsha, Hunan, China

Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

The first hospital of Jilin University

Changchun, Jilin, China

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)

Jinan, Shandong, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

West China Hospital,Sichuan University

Chengdu, Sichuan, China

The Second Affiliated Hospital of Kunming Medical UniversityThe Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China