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RecruitingNCT07059650Updated Apr 1, 2026

DZD8586 Combination Therapy in Patients With Diffuse Large B-cell Lymphoma (TAI-SHAN12)

A Phase 1/2 interventional study of DZD8586+R-CHOP and DZD8586+R-GemOx in Diffuse Large B-Cell Lymphoma, sponsored by Dizal Pharmaceuticals. Recruiting at 13 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by Dizal Pharmaceuticals · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 1 month later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. It will also measure the levels of DZD8586 in the body when combined with immunochemotherapy regimens.

02

Conditions studied

  • Diffuse Large B-Cell Lymphoma
03

In context

Lymphoma, Large B-Cell, Diffuse

1,390 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 350 are open to participants now.

This study's planned enrollment of 150 is above the median of 47 across 1,185 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.

Browse Lymphoma, Large B-Cell, Diffuse studies →

Lead sponsor

Dizal Pharmaceuticals is the lead sponsor of 37 studies on the registry; 15 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 1 (7%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Cohort 1:

    1. Patients with pathologically confirmed DLBCL who have not received prior anti-lymphoma therapy.
    2. Disease stage II to IV by Ann Arbor Classification.
    3. Life expectancy ≥ 12 months.

  • Cohort 2, 3:

    1. Pathologically confirmed DLBCL patients who have received adequate first-line treatment containing CD20 monoclonal antibody and anthracyclines (such as R-CHOP-like regimen).
    2. Relapsed or refractory to first-line R-CHOP-like regimen.
    3. 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.
    4. Life expectancy ≥ 6 months.

  • Patients must also meet all of the following criteria to be included in this study:

    1. All patients must provide a signed and dated written informed consent prior to any study-specific procedure, sampling, and analysis.
    2. Patients must be ≥ 18 years of age at the time of informed consent.
    3. ECOG status score of 0 to 2.
    4. 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.
    5. Adequate bone marrow hematopoietic reserve and organ function.
    6. No uncontrolled medical complications.
    7. Patients should be able to follow the relevant requirements of this study for medication and follow-up.
    8. Willing to comply with contraceptive restrictions.

Exclusion criteria

Exclusion Criteria:

  • Cohort 2, 3:

    a. 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:

    1. Indolent lymphoma-transformed DLBCL, primary mediastinal lymphoma, lymphoma involving the central nervous system, or DLBCL with MYC and BCL2 rearrangements.
    2. Prior use of BTK inhibitors.
    3. Vaccination with live attenuated vaccines or viral vector vaccines within 4 weeks prior to enrollment.
    4. 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.
    5. 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.
    6. Clinically significant cardiac disorders. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
    7. Active infectious diseases.
    8. 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.
    9. The patient has been diagnosed with other malignant diseases other than B-cell lymphoma within the past 2 years.
    10. Patients with hypersensitivity to DZD8586 drug excipients or other chemical analogues.
    11. Patients with severe or uncontrolled systemic diseases, including poorly controlled hypertension and active bleeding constitution.
    12. Serious medical or psychiatric illness that could affect participation in the study or could compromise the ability to consent
    13. Women who are pregnant or breastfeeding.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    DZD8586 combination therapy

    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.

    Drug: DZD8586+R-CHOP · Drug: DZD8586+R-GemOx · Drug: DZD8586+BR

Interventions

  • DrugDZD8586+R-CHOP

    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.

  • DrugDZD8586+R-GemOx

    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.

  • DrugDZD8586+BR

    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.

06

What researchers measure

Primary outcomes

  1. Part A: Incidence and severity of adverse events

    Time frame: Approximately 5 years

  2. Part B: Objective response rate (ORR)

    Time frame: Approximately 5 years

Secondary outcomes

  1. Part A: Objective response rate (ORR)

    Time frame: Approximately 5 years

  2. Part A: Complete response rate (CRR)

    Time frame: Approximately 5 years

  3. Part A: Time to response (TTR)

    Time frame: Approximately 5 years

  4. Part A: Duration of Response (DoR)

    Time frame: Approximately 5 years

  5. Part A: Progression-Free Survival (PFS)

    Time frame: Approximately 5 years

  6. Part A: Overall Survival (OS)

    Time frame: Approximately 5 years

  7. Part B: Incidence and severity of adverse events

    Time frame: Approximately 5 years

  8. Part B: Complete response rate (CRR)

    Time frame: Approximately 5 years

  9. Part B: Time to response (TTR)

    Time frame: Approximately 5 years

  10. Part B: Duration of Response (DoR)

    Time frame: Approximately 5 years

  11. Part B: Progression-Free Survival (PFS)

    Time frame: Approximately 5 years

  12. Part B: Overall Survival (OS)

    Time frame: Approximately 5 years

  13. Part A: Peak plasma concentration (Cmax) of DZD8586 and metabolite (DZ4581)

    Time frame: Up to 24 hours post dose

  14. Part A: Area under the plasma concentration versus time curve (AUC) of DZD8586 and metabolite (DZ4581)

    Time frame: Up to 24 hours post dose

  15. Part A: Time to peak concentration (Tmax) of DZD8586 and metabolite (DZ4581)

    Time frame: Up to 24 hours post dose

  16. 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

  17. Part A: Trough concentration at steady state (Css, min) of DZD8586 and metabolite (DZ4581)

    Time frame: Up to 24 hours post dose

  18. Part A: Apparent clearance at steady state (CLss/F) of DZD8586

    Time frame: Up to 24 hours post dose

  19. 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

  20. Part A: Accumulation index in peak plasma concentration (RACCmax) of DZD8586 and metabolite (DZ4581)

    Time frame: Up to 24 hours post dose

07

Study locations

12 of 13 sites recruiting
  • Peking University Third Hospital
    Beijing, China
    Recruiting
  • Hunan Cancer Hospital
    Changsha, China
    Not yet recruiting
  • West China Hospital of Sichuan University
    Chengdu, China
    Recruiting
  • Guangdong Provincial People's Hospital
    Guangzhou, China
    Recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, China
    Recruiting
  • Zhujiang Hospital of Southern Medical University
    Guangzhou, China
    Recruiting
  • The Second Affiliated Hospital Zhejiang University School of Medicine
    Hangzhou, China
    Recruiting
  • Anhui Provincial Cancer Hospital
    Hefei, China
    Recruiting
  • Linyi Cancer Hospital
    Linyi, China
    Recruiting
  • Shanxi Cancer Hospital
    Taiyuan, China
    Recruiting
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, China
    Recruiting
  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, China
    Recruiting
  • Henan Cancer Hospital
    Zhengzhou, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07059650
Lead sponsor
Dizal Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 11, 2025
Start date
Aug 19, 2025
Primary completion
Oct 2030 (estimated)
Completion
Oct 2030 (estimated)
Last update
Apr 1, 2026

Study contacts

Mengling Zhong
Contact
mengling.zhong@dizalpharma.com
+86-21-61095852
Huang
principal investigator · Sun Yat-Sen University Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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