NCT07496229 Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3)
| NCT ID | NCT07496229 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Dizal Pharmaceuticals |
| Condition | T-cell Lymphomas |
| Study Type | INTERVENTIONAL |
| Enrollment | 165 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2029-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 165 participants in total. It began in 2026-04-15 with a primary completion date of 2029-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07496229 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying T-cell Lymphomas. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07496229 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07496229 currently recruiting?
Yes, NCT07496229 is actively recruiting participants. Contact the research team at jingrun.li@dizalpharma.com for enrollment information.
Where is the NCT07496229 trial being conducted?
This trial is being conducted at Chongqing, China, Fuzhou, China, Nanning, China, Zhengzhou, China and 8 additional locations.
Who is sponsoring the NCT07496229 clinical trial?
NCT07496229 is sponsored by Dizal Pharmaceuticals. The trial plans to enroll 165 participants.