Clinical Trials in China / NCT07124936
Recruiting
Phase 1/2
A Study of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma
NCT07124936 · tracked via the Priya Life Science China tracker
Condition(s) studied
Diffuse Large B Cell Lymphoma (DLBCL)
Investigational drug(s) / intervention(s)
HDM2005 →Rituximab or Rituximab biosimilarAll Rituximab trials (254) →All Rituximab Biosimilar trials (5) →Gemcitabine →Oxaliplatin →Cyclophosphamide →Doxorubicin →Prednisone →
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.
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.
Eligibility
Inclusion Criteria:
1. Male or female aged 18-75 years.
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:
1. Known active central nervous system (CNS) lymphoma.
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.
Primary outcome measure(s)
- Number of participants who experience dose-limiting toxicities (DLTs) in dose-escalation part — Up to ~3 weeks
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. - Number of participants who experience adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) in dose-escalation part — Up to ~54 months
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. - Complete response (CR) rate in dose-expansion part — Up to ~30 months
CR rate is defined as the percentage of participants who achieve a complete response (CR) per Lugano criteria, as determined by the investigator - RP2D of HDM2005 — Up to ~30 months
Recommended phase 2 dose of HDM2005 in combination with SoC in patients with r/r DLBCL and untreated DLBCL
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University Cancer Hospital | Beijing | Beijing Municipality | Recruiting |
| Fujian Cancer Hospital | Fuzhou | Fujian | Not Yet Recruiting |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | Not Yet Recruiting |
| The Affiliated Tumor Hospital of Guangxi Medical University | Nanning | Guangxi | Not Yet Recruiting |
| Affiliated Tumor Hospital of Harbin Medical University | Harbin | Heilongjiang | Not Yet Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | Not Yet Recruiting |
| Henan Cancer Hospital | Zhengzhou | Henan | Not Yet Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Not Yet Recruiting |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Not Yet Recruiting |
| HunanCancer Hospital | Changsha | Hunan | Not Yet Recruiting |
| Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | Not Yet Recruiting |
| The First Affiliated Hospital Of Nanchang University | Nanchang | Jiangxi | Not Yet Recruiting |
| The first hospital of Jilin University | Changchun | Jilin | Not Yet Recruiting |
| Shengjing Hospital Affiliated to China Medical University | Shenyang | Liaoning | Not Yet Recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | Not Yet Recruiting |
| Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital) | Jinan | Shandong | Not Yet Recruiting |
| Shanxi Cancer Hospital | Taiyuan | Shanxi | Not Yet Recruiting |
| West China Hospital，Sichuan University | Chengdu | Sichuan | Not Yet Recruiting |
| The Second Affiliated Hospital of Kunming Medical UniversityThe Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | Active Not Recruiting |
| Yunnan Cancer Hospital | Kunming | Yunnan | Not Yet Recruiting |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | Not Yet Recruiting |
On this site
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07124936 on ClinicalTrials.gov ↗ ← All trials in China