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

Recruiting now · Phase 1/Phase 2

Conditions studied: Diffuse Large B Cell Lymphoma (DLBCL)

In brief

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.

Key facts

Study ID

NCT07124936

Run by

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

People needed

97

Starts

2025-07-30

Expected to finish

2029-10-25

Last updated by the study team

2025-08-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female aged 18-75 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy >12 weeks.
• Histologically confirmed diffuse large B-cell lymphoma (DLBCL).
• a. Cohort B: International Prognostic Index (IPI) score of 2-5.
• Prior treatment:
• Cohort A: At least one (≥1) line of prior systemic therapy.
• Cohort B: Has received no prior treatment for DLBCL.
• At least one bi-dimensionally measurable (≥1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥1 cm) extranodal lesion, as measured on computed tomography (CT) scan.
• Adequate organ system and hematologic function as defined in protocol.

You may not qualify if…

• Known active central nervous system (CNS) lymphoma.
• Prior of allogeneic hematopoietic stem cell transplantation and has acute or ongoing graft-versus-host disease (GVHD) of any grade.
• Known additional malignancy that is progressing or has required active treatment within the past 3 years.
• History of severe bleeding disorders.
• History of interstitial lung disease or radiation pneumonitis.
• Prior solid organ transplant.
• Ongoing Grade >1 treatment-related adverse events.
• Current or history of clinically significant cardiovascular and cerebrovascular diseases.
• Active infection requiring systemic therapy.
• Concurrent active HBV or HCV infection or known history of human immunodeficiency virus (HIV) infection.
• Prior ROR1-targeted therapy.
• Ongoing corticosteroid therapy.
• Current active autoimmune disease or history of autoimmune disease requiring treatment.
• History of drug anaphylaxis or severe food allergy.
• Any history or current evidence of disease, treatment, or laboratory abnormality as determined by the investigator that may affect the study results, interfere with the subject's full participation in the study, or be contrary to the subject's best interests.

Where it is running

• Peking University Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
• 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

Full record on ClinicalTrials.gov

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