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

April 16, 2026 updated by: Dizal Pharmaceuticals

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

165

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Tao
      • Taiyuan, China
        • Not yet recruiting
        • Shanxi Provincial Cancer Hospital
        • Contact:
          • Su
      • Zhengzhou, China
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
          • Zhou
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Not yet recruiting
        • Chongqing Cancer Hospital
        • Contact:
          • Liu
    • Fujian
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
          • He
    • Guangxi
      • Nanning, Guangxi, China
        • Not yet recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
          • Cen
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • Zhu
    • Hubei
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Zhang
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
          • Xu
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Zou
    • Zhejiang
      • Taizhou, Zhejiang, China
        • Not yet recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
          • Guo
      • Wenzhou, Zhejiang, China
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Shen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose escalation cohorts (Part A, non-randomized)
Drug: GW5282 combined with Golidocitinib
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.
Drug: GW5282 combined with Golidocitinib
GW5282 and Golidocitinib will be administered at the doses determined during escalation part.
Experimental: Dose expansion cohorts (Part B, randomized)
Drug: GW5282 combined with Golidocitinib
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.
Drug: GW5282 combined with Golidocitinib
GW5282 and Golidocitinib will be administered at the doses determined during escalation part.
Experimental: Control cohort (Part B, randomized)
Drug: Conventional CHOP regimen
CHOP regimen includes the administrations of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
To evaluate the safety and tolerability of the combination of GW5282 and golidocitinib. Dose Limiting Toxicity (DLT) was evaluated in the DLT observation frame.
The DLT observation period is defined as the 21 days after the first dose.
Part B: Complete Response Rate (CRR) According to Lugano 2014 by Investigators' Review
Time Frame: Up to 6 cycles, each cycle is 21 days
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.
Up to 6 cycles, each cycle is 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: Plasma concentration of GW5282 and golidocitinib
Time Frame: C1D1, C1D15, and Day 1 of Cycle 2~9
To characterize the pharmacokinetics of GW5282 and golidocitinib when orally given together
C1D1, C1D15, and Day 1 of Cycle 2~9
Part A: Efficacy parameters
Time Frame: through the study completion, an average of around 1~2 years
To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Objective Response Rate (ORR)
through the study completion, an average of around 1~2 years
Part A: Efficacy parameters
Time Frame: through the study completion, an average of around 1~2 years
To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Complete Response Rate (CRR)
through the study completion, an average of around 1~2 years
Part A: Efficacy parameters
Time Frame: through the study completion, an average of around 1~2 years
To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Duration of Response (DoR)
through the study completion, an average of around 1~2 years
Part A: Efficacy parameters
Time Frame: through the study completion, an average of around 1~2 years
To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Progression Free Survival (PFS)
through the study completion, an average of around 1~2 years
Part B: Other efficacy parameters
Time Frame: through the study completion, an average of around 1~2 years
To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: ORR
through the study completion, an average of around 1~2 years
Part B: Other efficacy parameters
Time Frame: through the study completion, an average of around 1~2 years
To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: DoR
through the study completion, an average of around 1~2 years
Part B: Other efficacy parameters
Time Frame: through the study completion, an average of around 1~2 years
To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoints: PFS.
through the study completion, an average of around 1~2 years
Part B: Adverse Events (AEs) / Serious Adverse Events (SAEs)
Time Frame: through the study completion, an average of around 1~2 years
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.
through the study completion, an average of around 1~2 years
Part B: Plasma concentration of GW5282 and golidocitinib
Time Frame: C1D1, C1D15, and Day 1 of subsequent cycles till treatment discontinuation
To characterize the pharmacokinetics of GW5282 and golidocitinib when orally given together
C1D1, C1D15, and Day 1 of subsequent cycles till treatment discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dizal Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GW2025EZ0002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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