GW5282 with golidocitinib versus CHOP for peripheral T‑cell lymphoma

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

This will test whether combining GW5282 with golidocitinib helps adults with peripheral T‑cell lymphoma more than standard CHOP chemotherapy.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 165 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dizal Pharmaceuticals (Industry-sponsored)
• Drugs / interventions: golidocitinib
• Locations: 12 sites (Chongqing, Chongqing Municipality and 11 other locations)
• Trial ID: NCT07496229 on ClinicalTrials.gov

What this trial studies

This open‑label phase 1/2 program begins with a dose‑escalation phase to determine the maximum tolerated dose of GW5282 given with golidocitinib. After a recommended phase 2 dose is identified, participants will be randomized in a controlled phase to compare the combination regimen against conventional CHOP chemotherapy for preliminary signals of efficacy and safety. The trial enrolls adults with histologically confirmed peripheral T‑cell lymphoma and measurable disease and requires adequate organ function and performance status. The study is conducted at multiple cancer centers in China.

Who should consider this trial

Good fit: Adults (≥18) with histopathologically confirmed peripheral T‑cell lymphoma, measurable disease, ECOG ≤2, life expectancy ≥12 weeks, and adequate marrow and organ function who can comply with study procedures are ideal candidates.

Not a fit: Patients with central nervous system lymphoma involvement, unresolved significant drug‑related adverse events, inability to complete required washout periods, or inadequate organ function are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the combination could produce higher response rates or longer remissions than CHOP while maintaining an acceptable safety profile.

How similar studies have performed: Early‑phase work with JAK inhibitors and other targeted agents in T‑cell lymphomas has shown activity in some patients, but the specific GW5282 plus golidocitinib combination is novel with limited prior data.

Eligibility criteria

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.

Where this trial is running

Chongqing, Chongqing Municipality and 11 other locations

• Chongqing Cancer Hospital — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (Not_yet_recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
• Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Not_yet_recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
• Shanxi Provincial Cancer Hospital — Taiyuan, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhengzhou, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Jingrun Li

Conditions T-cell Lymphomas