Actively Recruiting
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
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-08-15
97
Participants Needed
21
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and antitumor activity of HDM2005 combined with standard treatments in people with diffuse large B-cell lymphoma (DLBCL). This phase 1b/2 study focuses on two groups: those with relapsed or refractory DLBCL and those newly diagnosed without prior treatment. The study is designed to explore appropriate dosing and expand treatment options for these patients. Participants with relapsed or refractory DLBCL (Cohort A) will receive HDM2005 alongside a combination of rituximab, gemcitabine, and oxaliplatin. Those with untreated DLBCL (Cohort B) will receive HDM2005 with rituximab, cyclophosphamide, doxorubicin, and prednisone. Treatments are given in cycles every three weeks, with Cohort A receiving up to 6-8 cycles and Cohort B up to 6 cycles. HDM2005 and other drugs are administered intravenously except prednisone, which is taken orally. Throughout the study, participants will undergo regular assessments to monitor side effects, tumor response, and drug levels. Researchers will track dose-limiting toxicities, complete response rates, and other health outcomes for up to several years. The study includes a dose-escalation phase to find the right dose and a dose-expansion phase to further evaluate treatment effects and safety over time.
CONDITIONS
Brief 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 untreated DLBCL (Cohort B), International Prognostic Index (IPI) score of 2-5
- Prior treatment: at least one line of systemic therapy for relapsed/refractory DLBCL (Cohort A); no prior treatment for untreated DLBCL (Cohort B)
- At least one measurable nodal lesion (≥1.5 cm) or extranodal lesion (≥1 cm) on CT scan
- Adequate organ and blood function as defined in the protocol
You will not qualify if you...
- Known active central nervous system (CNS) lymphoma
- Prior allogeneic hematopoietic stem cell transplant with acute or ongoing graft-versus-host disease (GVHD)
- Active or progressing additional malignancy requiring treatment within past 3 years
- History of severe bleeding disorders
- History of interstitial lung disease or radiation pneumonitis
- Prior solid organ transplant
- Ongoing treatment-related adverse events greater than Grade 1
- Current or past significant cardiovascular or cerebrovascular disease
- Active infection requiring systemic therapy
- Current active hepatitis B or C infection or known HIV infection
- Prior treatment targeting ROR1
- Ongoing corticosteroid therapy
- Current or history of autoimmune disease requiring treatment
- History of drug anaphylaxis or severe food allergy
- Any other condition or abnormality that may affect study participation or results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 to 24 weeks (6 to 8 cycles of 3 weeks each)
Participants receive HDM2005 in combination with other intravenous drugs and oral prednisone according to their cohort, administered in 3-week cycles.
Up to 6 to 8 visits (in-person) every 3 weeks during treatment cycles
Duration - Up to approximately 54 months
Participants are monitored for safety, tolerability, and antitumor activity after completing treatment.
Regular visits as determined by the study protocol
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here