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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDizal Pharmaceuticals

About this trial

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 criteria

Qualifiers

Signed informed consent;

Adult ≥ 18 years of age;

ECOG performance status score ≤ 2;

Life expectancy of not less than 12 weeks;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • GW5282 combined with Golidocitinib
  • GW5282 combined with Golidocitinib
  • Conventional CHOP regimen

Treatment groups

165 Participants
are divided into 3 treatment groups

Locations

12
Chongqing Cancer Hospital ChongqingChongqing Municipality, China
Fujian Cancer Hospital FuzhouFujian, China
Guangxi Medical University Cancer Hospital NanningGuangxi, China
Henan Provincial People's Hospital ZhengzhouHenan, China

Sponsors and collaborators

Dizal Pharmaceuticals

Lead sponsor