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T-cell LymphomasPhase 1/2NCT07496229

Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3)

A Phase 1/2 study testing GW5282 combined with Golidocitinib and Conventional CHOP regimen in people with T-cell Lymphomas, run by Dizal Pharmaceuticals at 12 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a phase 1/2 open-label study to evaluate GW5282 in combination with golidocitinib (G2 regimen) for the treatment of T-cell lymphoma. In the first phase of the study, the maximum tolerated dose will be determined through dose escalation; in the second phase, the potential therapeutic advantages of the novel… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
T-cell Lymphomas
What is being tested?
GW5282 combined with Golidocitinib and Conventional CHOP regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
12 sitesChina
Study dates
15 Apr 2026to Dec 2029
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

  • Signed informed consent;
  • Adult ≥ 18 years of age;
  • ECOG performance status score ≤ 2;
  • Life expectancy of not less than 12 weeks;
  • Histopathologically confirmed diagnosis of PTCL;
  • Presence of measurable disease;
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  • Adequate bone marrow function and vital organ function reserve;
  • Ability to comply with study requirements and to complete study-related procedures;
  • Adequate contraception during participation in the trial.

Who cannot join

  • Presence of unresolved drug-related adverse events greater than Grade 1;
  • Lymphoma involving the central nervous system;
  • Failure to complete the required washout period for other anti-tumor therapies;
  • Corticosteroid use that does not meet protocol requirements;
  • Major surgery/trauma within a short period, or planned major surgery within a short period;
  • Vaccination with a live vaccine within a short period;
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  • Inability to discontinue prohibited medications;
  • Requirement for immunosuppressive agents or biologics due to an underlying disease;
  • Presence of active infection;
  • Significant cardiovascular disease;
  • Presence of gastrointestinal disease that might affect drug intake or absorption;
  • History of other malignancies;
  • Known allergy to the study drug;
  • Other severe or uncontrolled systemic diseases;
  • Personnel with a conflict of interest (e.g., site staff, sponsor employees);
  • Pregnant or breastfeeding women;
  • Inability to comply with protocol requirements.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jingrun Li contact

+86-21-61097800

jingrun.li@dizalpharma.com

12 sites in 1 country

China12 sites, 12 recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Zou

    Not yet recruiting

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality

    Liu

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    He

    Not yet recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

    Xu

    Not yet recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi

    Cen

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Tao

    Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan

    Su

    Not yet recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

    Guo

    Not yet recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Shen

    Not yet recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Zhang

    Not yet recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

    Zhu

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Zhou

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase I/II Clinical Study to Evaluate the Efficacy and Safety of GW5282 in Combination With Golidocitinib in the Treatment of T-Cell Lymphoma

This is a phase 1/2 open-label study to evaluate GW5282 in combination with golidocitinib (G2 regimen) for the treatment of T-cell lymphoma. In the first phase of the study, the maximum tolerated dose will be determined through dose escalation; in the second phase, the potential therapeutic advantages of the novel combination therapy over the conventional CHOP regimen will be preliminarily assessed through a randomized controlled design.

Being tested
GW5282 combined with Golidocitinib, Conventional CHOP regimen
Medical subject headings
Lymphoma, T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GW5282 combined with GolidocitinibDrug

    GW5282 and Golidocitinib will be administered in combination as twice daily (BID) and once daily (QD), respectively. The starting dose will be GW5282 40 mg BID combined with golidocitinib 150 mg QD. If tolerated, the dose of GW5282 will be subsequently escalated.

  • GW5282 combined with GolidocitinibDrug

    GW5282 and Golidocitinib will be administered at the doses determined during escalation part.

  • Conventional CHOP regimenDrug

    CHOP regimen includes the administrations of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.

  • GW5282 combined with GolidocitinibDrug

    GW5282 and Golidocitinib will be administered at the doses determined during escalation part.

Study groups in NCT07496229
Study groupRoleWhat they receive
Dose escalation cohorts (Part A, non-randomized)ExperimentalNot described
Receives: Drug: GW5282 combined with Golidocitinib
Dose expansion cohorts (Part B, randomized)ExperimentalNot described
Receives: Drug: GW5282 combined with Golidocitinib
Control cohort (Part B, randomized)ExperimentalNot described
Receives: Drug: Conventional CHOP regimen
Dose confirmation cohort (Part A, non-randomized)ExperimentalNot described
Receives: Drug: GW5282 combined with Golidocitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

    To evaluate the safety and tolerability of the combination of GW5282 and golidocitinib. Dose Limiting Toxicity (DLT) was evaluated in the DLT observation frame.

    Measured: The DLT observation period is defined as the 21 days after the first dose.

  2. Part B: Complete Response Rate (CRR) According to Lugano 2014 by Investigators' Review

    To evaluate anti-tumor activity of GW5282 combined with golidocitinib as a chemo-free induction therapy for newly diagnosed PTCL, and compare it with conventional CHOP regimen.

    Measured: Up to 6 cycles, each cycle is 21 days

Secondary outcomes (10)

  1. Part A: Plasma concentration of GW5282 and golidocitinib

    To characterize the pharmacokinetics of GW5282 and golidocitinib when orally given together

    Measured: C1D1, C1D15, and Day 1 of Cycle 2~9

  2. Part A: Efficacy parameters

    To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Objective Response Rate (ORR)

    Measured: through the study completion, an average of around 1~2 years

  3. Part A: Efficacy parameters

    To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Complete Response Rate (CRR)

    Measured: through the study completion, an average of around 1~2 years

  4. Part A: Efficacy parameters

    To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Duration of Response (DoR)

    Measured: through the study completion, an average of around 1~2 years

  5. Part A: Efficacy parameters

    To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Progression Free Survival (PFS)

    Measured: through the study completion, an average of around 1~2 years

  6. Part B: Other efficacy parameters

    To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: ORR

    Measured: through the study completion, an average of around 1~2 years

  7. Part B: Other efficacy parameters

    To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: DoR

    Measured: through the study completion, an average of around 1~2 years

  8. Part B: Other efficacy parameters

    To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoints: PFS.

    Measured: through the study completion, an average of around 1~2 years

  9. Part B: Adverse Events (AEs) / Serious Adverse Events (SAEs)

    To determine the safety and tolerability of GW5282 combined with golidocitinib: Number of Participants With AEs, Number of Participants With SAEs. Using investigator reported AEs according to CTCAE and SAE criteria.

    Measured: through the study completion, an average of around 1~2 years

  10. Part B: Plasma concentration of GW5282 and golidocitinib

    To characterize the pharmacokinetics of GW5282 and golidocitinib when orally given together

    Measured: C1D1, C1D15, and Day 1 of subsequent cycles till treatment discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start15 Apr 2026
  3. Primary completionSep 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07496229
Sponsor's protocol ID
GW2025EZ0002
Status last verified
Apr 2026
First submitted
16 Mar 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GW5282 combined with Golidocitinib and Conventional CHOP regimen in people with T-cell Lymphomas, run by Dizal Pharmaceuticals at 12 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 9 inclusion and 17 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 Jingrun Li (+86-21-61097800, jingrun.li@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 of Treatment-Emergent Adverse Events [Safety and Tolerability]). (time frame: The DLT observation period is defined as the 21 days after the first dose.). 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?

On the ClinicalTrials.gov record for NCT07496229.

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 22 Oct 2026.

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