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NCT Number: NCT07496229

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

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.

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Key information

Conditions

T-cell Lymphomas Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chongqing Cancer Hospital, Chongqing, Chongqing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

GW5282 combined with Golidocitinib

Drug

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.

Conventional CHOP regimen

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jingrun Li

CONTACT

[email protected]

+86-21-61097800

Sponsors and collaborators

Lead sponsor

Dizal Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 27, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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