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

Dizal Pharma

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: T-cell Lymphomas

Treatments: Drug: Conventional CHOP regimen; Drug: GW5282 combined with Golidocitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07496229

GW2025EZ0002

Details and patient eligibility

About

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.

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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165 participants in 3 patient groups

Dose escalation cohorts (Part A, non-randomized)

Experimental group

Treatment:

Drug: GW5282 combined with Golidocitinib

Drug: GW5282 combined with Golidocitinib

Dose expansion cohorts (Part B, randomized)

Experimental group

Treatment:

Drug: GW5282 combined with Golidocitinib

Drug: GW5282 combined with Golidocitinib

Control cohort (Part B, randomized)

Experimental group

Treatment:

Drug: Conventional CHOP regimen