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

NCT07124936 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-08-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2027-10-26
Completion
2029-10-25

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07124936 on ClinicalTrials.gov