Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3)
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
Dizal Pharmaceuticals
165 participants
Apr 15, 2026
INTERVENTIONAL
Conditions
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 combination therapy over the conventional CHOP regimen will be preliminarily assessed through a randomized controlled design.
Eligibility
Inclusion Criteria9
- 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 Criteria17
- 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.
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Interventions
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 and Golidocitinib will be administered at the doses determined during escalation part.
CHOP regimen includes the administrations of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07496229