Diffuse Large B-Cell LymphomaPhase 1/2NCT07059650
DZD8586 Combination Therapy in Patients With Diffuse Large B-cell Lymphoma (TAI-SHAN12)
A Phase 1/2 study testing DZD8586+R-CHOP, DZD8586+R-GemOx and DZD8586+BR in people with Diffuse Large B-Cell Lymphoma, run by Dizal Pharmaceuticals at 13 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- DZD8586+R-CHOP, DZD8586+R-GemOx and DZD8586+BR
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 13 sitesChina
- Study dates
- 19 Aug 2025to Oct 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort 1:
- Patients with pathologically confirmed DLBCL who have not received prior anti-lymphoma therapy.
- Disease stage II to IV by Ann Arbor Classification.
- Life expectancy ≥ 12 months.
- Cohort 2, 3:
- Pathologically confirmed DLBCL patients who have received adequate first-line treatment containing CD20 monoclonal antibody and anthracyclines (such as R-CHOP-like regimen).
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- Relapsed or refractory to first-line R-CHOP-like regimen.
- For patients who have received only one line of therapy, if the patient has not received autologous stem cell transplantation, the investigator needs to assess as unsuitable or the patient refuses intensive chemotherapy and hematopoietic stem cell transplantation.
- Life expectancy ≥ 6 months.
- Patients must also meet all of the following criteria to be included in this study:
- All patients must provide a signed and dated written informed consent prior to any study-specific procedure, sampling, and analysis.
- Patients must be ≥ 18 years of age at the time of informed consent.
- ECOG status score of 0 to 2.
- Presence of at least one radiologically measurable lesion in 2 perpendicular directions as assessed by CT or MRI and a positive lesion on PET/CT scan consistent with a tumor site identified by CT or MRI.
- Adequate bone marrow hematopoietic reserve and organ function.
- No uncontrolled medical complications.
- Patients should be able to follow the relevant requirements of this study for medication and follow-up.
- Willing to comply with contraceptive restrictions.
Who cannot join
- Cohort 2, 3:
- Hematopoietic stem cell transplantation, cell therapy, or gene therapy within 90 days prior to first dose. Radiation therapy within 14 days prior to first dose. Chemotherapy and small-molecule targeted therapy were not terminated within 5 half-lives before the first dose; macromolecule drug therapy (such as antibody therapy) was not terminated within 28 days before the first dose.
- All patients should not be included in this study if they have any of the following conditions:
- Indolent lymphoma-transformed DLBCL, primary mediastinal lymphoma, lymphoma involving the central nervous system, or DLBCL with MYC and BCL2 rearrangements.
- Prior use of BTK inhibitors.
- Vaccination with live attenuated vaccines or viral vector vaccines within 4 weeks prior to enrollment.
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- Currently taking vitamin K antagonists, taking 2 or more antiplatelet/anticoagulant drugs at the same time, drugs/herbs or supplements known to potently induce or inhibit CYP3A enzyme activity, proton pump inhibitor drugs, anti-tumor traditional Chinese medicine or failing to meet the protocol-specified withdrawal time before administration in this study.
- Major surgery within 4 weeks or anticipated surgery after the start of this study. Or insufficiently recovered from any toxicity and/or complications of previous intervention.
- Clinically significant cardiac disorders. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
- Active infectious diseases.
- Intractable nausea and vomiting that cannot be well controlled by supportive treatment, chronic gastrointestinal diseases, dysphagia, or previous surgical resection of the intestinal segment may affect the adequate absorption of the drug.
- The patient has been diagnosed with other malignant diseases other than B-cell lymphoma within the past 2 years.
- Patients with hypersensitivity to DZD8586 drug excipients or other chemical analogues.
- Patients with severe or uncontrolled systemic diseases, including poorly controlled hypertension and active bleeding constitution.
- Serious medical or psychiatric illness that could affect participation in the study or could compromise the ability to consent
- Women who are pregnant or breastfeeding.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Jing, bysyjhm@sina.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha
Li, liyajun@hnca.org.cn
- Recruiting
West China Hospital of Sichuan University
Chengdu
Zou, zliqun@hotmail.com
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou
Li, liwy1206@163.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Huang, huanghq@sysucc.org.cn
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou
Li, liyuhua2011gz@163.com
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Liang, liangyun@zju.edu.com
- Recruiting
Anhui Provincial Cancer Hospital
Hefei
Ding, dingkaiy@126.com
- Recruiting
Linyi Cancer Hospital
Linyi
Zheng, lymf666@126.com
- Recruiting
Shanxi Cancer Hospital
Taiyuan
Su, slpsy2022@163.com
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Zhu, zhufang1226@163.com
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
He, hepc@163.com
- Recruiting
Henan Cancer Hospital
Zhengzhou
Zhou, drzhouks77@163.com
About this study
Official title: A Phase Ib/II, Multicenter Study to Evaluate the Efficacy and Safety of DZD8586 Combination Therapy in Diffuse Large B-cell Lymphoma
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
- Diffuse Large B-Cell Lymphoma
- Being tested
- DZD8586+R-CHOP, DZD8586+R-GemOx, DZD8586+BR
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DZD8586+R-CHOPDrug
DZD8586 at the protocol defined dose level (50 mg or 75 mg, po, qd) with R-CHOP (Rituximab: 375 mg/m2, IV, d1; Cyclophosphamide: 750 mg/m2, IV, d1; Doxorubicin: 50 mg/m2, IV, d1; Vincristine: 1.4 mg/m2, IV, d1; Prednisone: 100 mg, po, d1-5) in a 21-day cycle for 6 cycles. DZD8586 (pre-defined dose level, po, qd) as maintenance therapy for CR/PR patients.
DZD8586+R-GemOxDrug
DZD8586 at the protocol defined dose level (50 mg or 75 mg, po, qd) with R-GemOx (Rituximab: 375 mg/m2, IV, d1; Gemcitabine: 1000 mg/m2, IV, d1; Oxaliplatin: 100 mg/m2, IV, d1) in a 21-day cycle for 8 cycles. DZD8586 (pre-defined dose level, po, qd) as maintenance therapy for CR/PR patients.
DZD8586+BRDrug
DZD8586 at the protocol defined dose level (50 mg or 75 mg, po, qd) with BR (Bendamustine: 90 mg/m2, IV, d1-d2; Rituximab: 375 mg/m2, IV, d1) in a 21-day cycle for 6 cycles. DZD8586 (pre-defined dose level, po, qd) as maintenance therapy for CR/PR patients.
| Study group | Role | What they receive |
|---|---|---|
| DZD8586 combination therapy | Experimental | 3 cohorts are included in this arm:
Cohort 1: Treatment naïve DLBCL patients will receive DZD8586 at the protocol defined dose level, combined with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimens for 6 cycles, and then DZD8586 as maintenance therapy for patients who achieved (complete response) CR or (partial response) PR after 6 cycles combination therapy.
Cohort 2: Relapsed/refractory DLBCL patients will receive DZD8586 at the protocol defined dose level, combined with R-GemOx (rituximab, gemcitabine, and oxaliplatin) regimens for 8 cycles, and then DZD8586 as maintenance therapy for patients who achieved CR or PR after 8 cycles combination therapy.
Cohort 3: Relapsed/refractory DLBCL patients will receive DZD8586 at the protocol defined dose level, combined with BR (bendamustine and rituximab) regimens for 6 cycles, and then DZD8586 as maintenance therapy for patients who achieved CR or PR after 6 cycles combination therapy. Receives: Drug: DZD8586+R-CHOP; Drug: DZD8586+R-GemOx; Drug: DZD8586+BR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Incidence and severity of adverse events
Measured: Approximately 5 years
Part B: Objective response rate (ORR)
Measured: Approximately 5 years
Secondary outcomes (20)
Part A: Objective response rate (ORR)
Measured: Approximately 5 years
Part A: Complete response rate (CRR)
Measured: Approximately 5 years
Part A: Time to response (TTR)
Measured: Approximately 5 years
Part A: Duration of Response (DoR)
Measured: Approximately 5 years
Part A: Progression-Free Survival (PFS)
Measured: Approximately 5 years
Part A: Overall Survival (OS)
Measured: Approximately 5 years
Part B: Incidence and severity of adverse events
Measured: Approximately 5 years
Part B: Complete response rate (CRR)
Measured: Approximately 5 years
Part B: Time to response (TTR)
Measured: Approximately 5 years
Part B: Duration of Response (DoR)
Measured: Approximately 5 years
Part B: Progression-Free Survival (PFS)
Measured: Approximately 5 years
Part B: Overall Survival (OS)
Measured: Approximately 5 years
Part A: Peak plasma concentration (Cmax) of DZD8586 and metabolite (DZ4581)
Measured: Up to 24 hours post dose
Part A: Area under the plasma concentration versus time curve (AUC) of DZD8586 and metabolite (DZ4581)
Measured: Up to 24 hours post dose
Part A: Time to peak concentration (Tmax) of DZD8586 and metabolite (DZ4581)
Measured: Up to 24 hours post dose
Part A: Metabolite (DZ4581) to parent (DZD8586) ratio based on area under the plasma concentration versus time curve (MRAUC)
Measured: Up to 24 hours post dose
Part A: Trough concentration at steady state (Css, min) of DZD8586 and metabolite (DZ4581)
Measured: Up to 24 hours post dose
Part A: Apparent clearance at steady state (CLss/F) of DZD8586
Measured: Up to 24 hours post dose
Part A: Accumulation index in area under the plasma concentration versus time curve (RACAUC) of DZD8586 and metabolite (DZ4581)
Measured: Up to 24 hours post dose
Part A: Accumulation index in peak plasma concentration (RACCmax) of DZD8586 and metabolite (DZ4581)
Measured: Up to 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start19 Aug 2025
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huang, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059650
- Sponsor's protocol ID
- DZ2024B0001
- Status last verified
- Mar 2026
- First submitted
- 16 Jun 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Multicenter Study to Evaluate the Efficacy and Safety of DZD8586 Combination Therapy in Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT07059650
- Acronym / sponsor ID
- DZ2024B0001
- Conditions
- Diffuse Large B-Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DZD8586 combination therapy | Experimental | Drug: DZD8586+R-CHOP, Drug: DZD8586+R-GemOx, Drug: DZD8586+BR3 cohorts are included in this arm: Cohort 1: Treatment naïve DLBCL patients will receive DZD8586 at the protocol defined dose level, combined with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimens for 6 cycles, and then DZD8586 as maintenance therapy for patients who achieved (complete response) CR or (partial response) PR after 6 cycles combination therapy. Cohort 2: Relapsed/refractory DLBCL patients will receive DZD8586 at the protocol defined dose level, combined with R-GemOx (rituximab, gemcitabine, and oxaliplatin) regimens for 8 cycles, and then DZD8586 as maintenance therapy for patients who achieved CR or PR after 8 cycles combination therapy. Cohort 3: Relapsed/refractory DLBCL patients will receive DZD8586 at the protocol defined dose level, combined with BR (bendamustine and rituximab) regimens for 6 cycles, and then DZD8586 as maintenance therapy for patients who achieved CR or PR after 6 cycles combination therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Cohort 1:
- Cohort 2, 3:
- Patients must also meet all of the following criteria to be included in this study:
Key exclusion criteria (16 listed)
- Cohort 2, 3:
- All patients should not be included in this study if they have any of the following conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DZD8586+R-CHOPDZD8586 at the protocol defined dose level (50 mg or 75 mg, po, qd) with R-CHOP (Rituximab: 375 mg/m2, IV, d1; Cyclophosphamide: 750 mg/m2, IV, d1; Doxorubicin: 50 mg/m2, IV, d1; Vincristine: 1.4 mg/m2, IV, d1; Prednisone: 100 mg, po, d1-5) in a 21-day cycle for 6 cycles. DZD8586 (pre-defined dose level, po, qd) as maintenance therapy for CR/PR patients. | Drug | DZD8586 combination therapy |
| DZD8586+R-GemOxDZD8586 at the protocol defined dose level (50 mg or 75 mg, po, qd) with R-GemOx (Rituximab: 375 mg/m2, IV, d1; Gemcitabine: 1000 mg/m2, IV, d1; Oxaliplatin: 100 mg/m2, IV, d1) in a 21-day cycle for 8 cycles. DZD8586 (pre-defined dose level, po, qd) as maintenance therapy for CR/PR patients. | Drug | DZD8586 combination therapy |
| DZD8586+BRDZD8586 at the protocol defined dose level (50 mg or 75 mg, po, qd) with BR (Bendamustine: 90 mg/m2, IV, d1-d2; Rituximab: 375 mg/m2, IV, d1) in a 21-day cycle for 6 cycles. DZD8586 (pre-defined dose level, po, qd) as maintenance therapy for CR/PR patients. | Drug | DZD8586 combination therapy |
Primary outcome
Part A: Incidence and severity of adverse events
Time frame: Approximately 5 years
Part B: Objective response rate (ORR)
Time frame: Approximately 5 years
20 secondary outcomes
Part A: Objective response rate (ORR)
Time frame: Approximately 5 years
Part A: Complete response rate (CRR)
Time frame: Approximately 5 years
Part A: Time to response (TTR)
Time frame: Approximately 5 years
Part A: Duration of Response (DoR)
Time frame: Approximately 5 years
Part A: Progression-Free Survival (PFS)
Time frame: Approximately 5 years
Part A: Overall Survival (OS)
Time frame: Approximately 5 years
Part B: Incidence and severity of adverse events
Time frame: Approximately 5 years
Part B: Complete response rate (CRR)
Time frame: Approximately 5 years
Part B: Time to response (TTR)
Time frame: Approximately 5 years
Part B: Duration of Response (DoR)
Time frame: Approximately 5 years
Part B: Progression-Free Survival (PFS)
Time frame: Approximately 5 years
Part B: Overall Survival (OS)
Time frame: Approximately 5 years
Part A: Peak plasma concentration (Cmax) of DZD8586 and metabolite (DZ4581)
Time frame: Up to 24 hours post dose
Part A: Area under the plasma concentration versus time curve (AUC) of DZD8586 and metabolite (DZ4581)
Time frame: Up to 24 hours post dose
Part A: Time to peak concentration (Tmax) of DZD8586 and metabolite (DZ4581)
Time frame: Up to 24 hours post dose
Part A: Metabolite (DZ4581) to parent (DZD8586) ratio based on area under the plasma concentration versus time curve (MRAUC)
Time frame: Up to 24 hours post dose
Part A: Trough concentration at steady state (Css, min) of DZD8586 and metabolite (DZ4581)
Time frame: Up to 24 hours post dose
Part A: Apparent clearance at steady state (CLss/F) of DZD8586
Time frame: Up to 24 hours post dose
Part A: Accumulation index in area under the plasma concentration versus time curve (RACAUC) of DZD8586 and metabolite (DZ4581)
Time frame: Up to 24 hours post dose
Part A: Accumulation index in peak plasma concentration (RACCmax) of DZD8586 and metabolite (DZ4581)
Time frame: Up to 24 hours post dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huang principal investigator
Sun Yat-Sen University Cancer Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DZD8586+R-CHOP, DZD8586+R-GemOx and DZD8586+BR in people with Diffuse Large B-Cell Lymphoma, run by Dizal Pharmaceuticals at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mengling Zhong (+86-21-61095852, mengling.zhong@dizalpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Incidence and severity of adverse events (time frame: Approximately 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.