NCT07124936

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 97 (estimated)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diffuse Large B Cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-30
• Primary completion: 2027-10-26
• Completion: 2029-10-25
• First posted: 2025-08-15
• Last updated: 2025-08-15

Locations

21 sites across 1 country: China