Actively Recruiting
DZD8586 Combination Therapy in Patients With Diffuse Large B-cell Lymphoma (TAI-SHAN12)
Led by Dizal Pharmaceuticals · Updated on 2026-04-01
150
Participants Needed
13
Research Sites
267 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will treat patients with diffuse large B-cell lymphoma (DLBCL). It will assess the anti-tumor efficacy and safety of DZD8586 combination therapy by using objective response rate and the incidence and severity of adverse events. It will also measure the levels of DZD8586 in the body when combined with immunochemotherapy regimens.
CONDITIONS
Official Title
DZD8586 Combination Therapy in Patients With Diffuse Large B-cell Lymphoma (TAI-SHAN12)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with pathologically confirmed diffuse large B-cell lymphoma (DLBCL)
- For Cohort 1: no prior anti-lymphoma treatment
- For Cohorts 2 and 3: patients who received first-line treatment including CD20 monoclonal antibody and anthracyclines and are relapsed or refractory
- Disease stage II to IV by Ann Arbor Classification (Cohort 1)
- Life expectancy of at least 12 months (Cohort 1) or at least 6 months (Cohorts 2 and 3)
- Age 18 years or older at informed consent
- ECOG performance status score between 0 and 2
- At least one measurable lesion on CT or MRI with positive PET/CT scan confirmation
- Adequate bone marrow and organ function
- No uncontrolled medical complications
- Ability to follow study medication and follow-up requirements
- Willingness to comply with contraceptive restrictions
- Signed and dated informed consent
You will not qualify if you...
- Hematopoietic stem cell transplantation, cell therapy, or gene therapy within 90 days prior to first dose (Cohorts 2, 3)
- Radiation therapy within 14 days prior to first dose (Cohorts 2, 3)
- Chemotherapy or small-molecule targeted therapy not stopped within 5 half-lives before first dose (Cohorts 2, 3)
- Macromolecule drug therapy (e.g., antibody therapy) not stopped within 28 days before first dose (Cohorts 2, 3)
- Indolent lymphoma-transformed DLBCL, primary mediastinal lymphoma, lymphoma involving central nervous system, or DLBCL with MYC and BCL2 rearrangements
- Prior use of BTK inhibitors
- Vaccination with live attenuated or viral vector vaccines within 4 weeks before enrollment
- Current use of vitamin K antagonists, multiple antiplatelet/anticoagulant drugs, CYP3A enzyme modulators, proton pump inhibitors, anti-tumor traditional Chinese medicine, or failure to meet withdrawal times
- Major surgery within 4 weeks or insufficient recovery from prior surgery
- Clinically significant cardiac disorders, history of thrombotic diseases, stroke, or intracranial hemorrhage within 6 months
- Active infectious diseases
- Uncontrolled nausea, vomiting, gastrointestinal diseases, swallowing difficulties, or prior intestinal surgery affecting drug absorption
- Other malignant diseases diagnosed within past 2 years (except B-cell lymphoma)
- Hypersensitivity to DZD8586 or related chemical analogues
- Severe or uncontrolled systemic diseases including poorly controlled hypertension and active bleeding
- Serious medical or psychiatric illness affecting study participation or consent
- Women who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 13 locations
1
Peking University Third Hospital
Beijing, China
Actively Recruiting
2
Hunan Cancer Hospital
Changsha, China
Not Yet Recruiting
3
West China Hospital of Sichuan University
Chengdu, China
Actively Recruiting
4
Guangdong Provincial People's Hospital
Guangzhou, China
Actively Recruiting
5
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
6
Zhujiang Hospital of Southern Medical University
Guangzhou, China
Actively Recruiting
7
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
8
Anhui Provincial Cancer Hospital
Hefei, China
Actively Recruiting
9
Linyi Cancer Hospital
Linyi, China
Actively Recruiting
10
Shanxi Cancer Hospital
Taiyuan, China
Actively Recruiting
11
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Actively Recruiting
12
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Actively Recruiting
13
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
Research Team
M
Mengling Zhong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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