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

Sponsors and collaborators