RecruitingPhase 1Phase 2NCT07124936

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

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

Sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Enrollment

97 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called HDM2005 in combination with standard chemotherapy for people with diffuse large B-cell lymphoma (DLBCL), an aggressive form of blood cancer, either as a first salvage treatment or for newly diagnosed high-risk patients. **You may be eligible if...** - You are 18–75 years old - You have confirmed diffuse large B-cell lymphoma (DLBCL) - You are in good overall physical health (ECOG 0 or 1) - You have a life expectancy greater than 12 weeks - For relapsed disease: you have had at least one prior treatment - For newly diagnosed high-risk disease: you have an IPI score of 2–5 **You may NOT be eligible if...** - Your lymphoma has spread to the brain or spinal fluid - You have active autoimmune conditions requiring treatment - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHDM2005

HDM2005 will be administered as an intravenous injection.

DRUGRituximab or Rituximab biosimilar

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

DRUGGemcitabine

Gemcitabine will be administered as an intravenous injection.

DRUGOxaliplatin

Oxaliplatin will be administered as an intravenous injection.

DRUGCyclophosphamide

Cyclophosphamide will be administered as an intravenous injection.

DRUGDoxorubicin

Doxorubicin will be administered as an intravenous injection.

DRUGPrednisone

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

View Full Details on ClinicalTrials.gov

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NCT07124936