A Study of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma
NCT ID: NCT07124936
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
97 participants
INTERVENTIONAL
2025-07-30
2029-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participants with r/r DLBCL (Cohort A)
Participants 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.
HDM2005
HDM2005 will be administered as an intravenous injection.
Rituximab or Rituximab biosimilar
Rituximab or Rituximab biosimilar will be administered as an intravenous injection.
Gemcitabine
Gemcitabine will be administered as an intravenous injection.
Oxaliplatin
Oxaliplatin will be administered as an intravenous injection.
Participants with untreated DLBCL (Cohort B)
Participants 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.
HDM2005
HDM2005 will be administered as an intravenous injection.
Rituximab or Rituximab biosimilar
Rituximab or Rituximab biosimilar will be administered as an intravenous injection.
Cyclophosphamide
Cyclophosphamide will be administered as an intravenous injection.
Doxorubicin
Doxorubicin will be administered as an intravenous injection.
Prednisone
Prednisone will be administered orally.
Interventions
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HDM2005
HDM2005 will be administered as an intravenous injection.
Rituximab or Rituximab biosimilar
Rituximab or Rituximab biosimilar will be administered as an intravenous injection.
Gemcitabine
Gemcitabine will be administered as an intravenous injection.
Oxaliplatin
Oxaliplatin will be administered as an intravenous injection.
Cyclophosphamide
Cyclophosphamide will be administered as an intravenous injection.
Doxorubicin
Doxorubicin will be administered as an intravenous injection.
Prednisone
Prednisone will be administered orally.
Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Life expectancy \>12 weeks.
4. Histologically confirmed diffuse large B-cell lymphoma (DLBCL).
a. Cohort B: International Prognostic Index (IPI) score of 2-5.
5. Prior treatment:
1. Cohort A: At least one (≥1) line of prior systemic therapy.
2. Cohort B: Has received no prior treatment for DLBCL.
6. 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.
7. Adequate organ system and hematologic function as defined in protocol.
Exclusion Criteria
2. Prior of allogeneic hematopoietic stem cell transplantation and has acute or ongoing graft-versus-host disease (GVHD) of any grade.
3. Known additional malignancy that is progressing or has required active treatment within the past 3 years.
4. History of severe bleeding disorders.
5. History of interstitial lung disease or radiation pneumonitis.
6. Prior solid organ transplant.
7. Ongoing Grade \>1 treatment-related adverse events.
8. Current or history of clinically significant cardiovascular and cerebrovascular diseases.
9. Active infection requiring systemic therapy.
10. Concurrent active HBV or HCV infection or known history of human immunodeficiency virus (HIV) infection.
11. Prior ROR1-targeted therapy.
12. Ongoing corticosteroid therapy.
13. Current active autoimmune disease or history of autoimmune disease requiring treatment.
14. History of drug anaphylaxis or severe food allergy.
15. 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.
18 Years
75 Years
ALL
No
Sponsors
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Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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HDM2005-104
Identifier Type: -
Identifier Source: org_study_id
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