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Diffuse Large B Cell Lymphoma (DLBCL)Phase 1/2NCT07124936

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

A Phase 1/2 study testing HDM2005, Rituximab or Rituximab biosimilar and Gemcitabine in people with Diffuse Large B Cell Lymphoma (DLBCL), run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 21 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diffuse Large B Cell Lymphoma (DLBCL)
What is being tested?
HDM2005, Rituximab or Rituximab biosimilar and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
21 sitesChina
Study dates
30 Jul 2025to 25 Oct 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • Cohort B: International Prognostic Index (IPI) score of 2-5.
  • Prior treatment:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Meiping Kong contact

+8613735478976

cxykongmeiping@eastchinapharm.com

21 sites in 1 country

China21 sites, 20 recruiting

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • The first hospital of Jilin University

    Changchun, Jilin, 130021

    Not yet recruiting

  • HunanCancer Hospital

    Changsha, Hunan, 410023

    Not yet recruiting

  • West China Hospital，Sichuan University

    Chengdu, Sichuan, 610041

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350000

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510050

    Not yet recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Not yet recruiting

  • Affiliated Tumor Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

    Not yet recruiting

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

    Jinan, Shandong, 250117

    Not yet recruiting

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

    Kunming, Yunnan, 650033

    Active, not recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

    Not yet recruiting

  • The First Affiliated Hospital Of Nanchang University

    Nanchang, Jiangxi, 330000

    Not yet recruiting

  • The Affiliated Tumor Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

    Not yet recruiting

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang, Liaoning, 110004

    Not yet recruiting

  • Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215005

    Not yet recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030013

    Not yet recruiting

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

    Wuhan, Hubei, 430022

    Not yet recruiting

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

    Wuhan, Hubei, 430030

    Not yet recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Not yet recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Not yet recruiting

Other trials in China

About this study

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

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.

Being tested
HDM2005, Rituximab or Rituximab biosimilar, Gemcitabine, Oxaliplatin, Cyclophosphamide
Keywords
DLBCL
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HDM2005Drug

    HDM2005 will be administered as an intravenous injection.

  • Rituximab or Rituximab biosimilarDrug

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

  • GemcitabineDrug

    Gemcitabine will be administered as an intravenous injection.

  • OxaliplatinDrug

    Oxaliplatin will be administered as an intravenous injection.

  • CyclophosphamideDrug

    Cyclophosphamide will be administered as an intravenous injection.

  • DoxorubicinDrug

    Doxorubicin will be administered as an intravenous injection.

  • PrednisoneDrug

    Prednisone will be administered orally.

Study groups in NCT07124936
Study groupRoleWhat they receive
Participants with r/r DLBCL (Cohort A)ExperimentalParticipants with r/r DLBCL will receive a dose of HDM2005 (1.8 mg/kg or 2.0 mg/kg, on Day 2 Cycle 1 and Day 1 Cycle 2 to 6-8) plus 1000 mg/ m^2 gemcitabine (on Day 2 Cycle 1 and Day 1 Cycle 2 to 6-8), 100 mg/ m^2 oxaliplatin, and 375 mg/m^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 6-8 cycles.
Receives: Drug: HDM2005; Drug: Rituximab or Rituximab biosimilar; Drug: Gemcitabine; Drug: Oxaliplatin
Participants with untreated DLBCL (Cohort B)ExperimentalParticipants with untreated DLBCL will receive a dose of HDM2005 (1.8 mg/kg or 2.0 mg/kg, on Day 2 Cycle 1 and Day 1 Cycle 2 to 6) plus 750 mg/m^2 cyclophosphamide (on Day 2 Cycle 1 and Day 1 Cycle 2 to 6), 50 mg/m^2 doxorubicin (on Day 2 Cycle 1 and Day 1 Cycle 2 to 6), and 375 mg/m^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 and 2 Cycle 1 and Day 1 Cycle 2 to 6 of each 3-week cycle for up to 6 cycles. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week cycle for up to 6 cycles.
Receives: Drug: HDM2005; Drug: Rituximab or Rituximab biosimilar; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants who experience dose-limiting toxicities (DLTs) in dose-escalation part

    The CTCAE, Version 5.0 will be used to grade the severity of AEs in this study. DLTs will be reported for dose-escalation part of this study.

    Measured: Up to ~3 weeks

  2. Number of participants who experience adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) in dose-escalation part

    Incidence and grading of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) (based on the National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE] version 5.0). Incidence of treatment interruption and dose adjustment due to AEs and changes in laboratory tests, vital signs, physical examination, electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status score.

    Measured: Up to ~54 months

  3. Complete response (CR) rate in dose-expansion part

    CR rate is defined as the percentage of participants who achieve a complete response (CR) per Lugano criteria, as determined by the investigator

    Measured: Up to ~30 months

  4. RP2D of HDM2005

    Recommended phase 2 dose of HDM2005 in combination with SoC in patients with r/r DLBCL and untreated DLBCL

    Measured: Up to ~30 months

Secondary outcomes (9)

  1. Plasma concentration of HDM2005, total antibody and monomethyl auristatin E (MMAE)

    Plasma concentration of HDM2005, total antibody and MMAE will be reported for each dose level

    Measured: Up to ~30 months

  2. Number of participants positive for anti-drug antibodies (ADA)

    Number of participants with positive ADA will be assessed

    Measured: Up to ~30 months

  3. Number of participants who experience adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) in dose-expansion part

    Incidence and grading of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) (based on the National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE] version 5.0). Incidence of treatment interruption and dose adjustment due to AEs and changes in laboratory tests, vital signs, physical examination, electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status score.

    Measured: Up to ~54 months

  4. Objective response rate (ORR)

    ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano criteria as determined by the investigator

    Measured: Up to ~30 months

  5. Progression-free survival (PFS)

    PFS is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression/relapse or death from any cause, whichever occurs first as determined by the investigator

    Measured: Up to ~54 months

  6. Duration of response (DOR)

    DOR is defined as the interval from the first documentation of CR or PR until disease progression or death due to any cause, whichever occurs first

    Measured: Up to ~54 months

  7. Time to response (TTR)

    TTR is defined as the interval from the start of study therapy to the first documentation of CR or PR

    Measured: Up to ~54 months

  8. Time to progression (TTP)

    TTP is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression as determined by the investigator

    Measured: Up to ~54 months

  9. Overall survival (OS)

    OS is defined as the time from randomization to death due to any cause

    Measured: Up to ~54 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2025
  2. Study start30 Jul 2025
  3. Primary completion26 Oct 2027 (estimated)
  4. Study completion25 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
97 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07124936
Sponsor's protocol ID
HDM2005-104
Status last verified
Aug 2025
First submitted
11 Aug 2025
Last updated
15 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HDM2005, Rituximab or Rituximab biosimilar and Gemcitabine in people with Diffuse Large B Cell Lymphoma (DLBCL), run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 21 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Meiping Kong (+8613735478976, cxykongmeiping@eastchinapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who experience dose-limiting toxicities (DLTs) in dose-escalation part (time frame: Up to ~3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07124936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.

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