Actively Recruiting
A Study of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-08-15
97
Participants Needed
21
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18-75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than 12 weeks
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL)
- For Cohort B: International Prognostic Index (IPI) score of 2-5
- Prior treatment: At least one line of prior systemic therapy for Cohort A
- No prior treatment for DLBCL for Cohort B
- At least one measurable nodal lesion (≥1.5 cm) or extranodal lesion (≥1 cm) on CT scan
- Adequate organ system and hematologic function as defined in protocol
You will not qualify if you...
- Known active central nervous system (CNS) lymphoma
- Prior allogeneic hematopoietic stem cell transplantation with acute or ongoing graft-versus-host disease (GVHD) of any grade
- Known additional malignancy progressing or treated within past 3 years
- History of severe bleeding disorders
- History of interstitial lung disease or radiation pneumonitis
- Prior solid organ transplant
- Ongoing Grade >1 treatment-related adverse events
- Current or history of significant cardiovascular or cerebrovascular diseases
- Active infection requiring systemic therapy
- Concurrent active HBV or HCV infection or known HIV infection
- Prior ROR1-targeted therapy
- Ongoing corticosteroid therapy
- Current active autoimmune disease or history requiring treatment
- History of drug anaphylaxis or severe food allergy
- Any disease, treatment, or lab abnormality that could affect study results or participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350000
Not Yet Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510050
Not Yet Recruiting
4
The Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Not Yet Recruiting
5
Affiliated Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
6
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
7
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Not Yet Recruiting
8
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Not Yet Recruiting
9
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Not Yet Recruiting
10
HunanCancer Hospital
Changsha, Hunan, China, 410023
Not Yet Recruiting
11
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215005
Not Yet Recruiting
12
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China, 330000
Not Yet Recruiting
13
The first hospital of Jilin University
Changchun, Jilin, China, 130021
Not Yet Recruiting
14
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China, 110004
Not Yet Recruiting
15
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Not Yet Recruiting
16
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
Jinan, Shandong, China, 250117
Not Yet Recruiting
17
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030013
Not Yet Recruiting
18
West China Hospital，Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
19
The Second Affiliated Hospital of Kunming Medical UniversityThe Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650033
Active, Not Recruiting
20
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Not Yet Recruiting
21
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
Research Team
M
Meiping Kong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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