Actively Recruiting
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
Led by Dizal Pharmaceuticals · Updated on 2026-04-17
165
Participants Needed
12
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of GW5282 and golidocitinib for treating T-cell lymphoma in a phase 1/2 open-label study. The study aims first to find the highest dose that can be tolerated safely through dose escalation. Then, it compares the new combination therapy to the standard CHOP regimen to see if it has potential benefits for patients with this type of lymphoma. The study has two parts. In the first part, participants receive GW5282 twice daily and golidocitinib once daily, starting at specific doses, with the possibility to increase GW5282 if tolerated. In the second part, patients are randomly assigned to receive either this combination at the established dose or the conventional CHOP chemotherapy regimen, which includes cyclophosphamide, doxorubicin, vincristine, and prednisone. Participants will be closely monitored for side effects during the 21 days after the first dose and throughout treatment cycles lasting 21 days each. Researchers will measure safety by recording adverse events and evaluate effectiveness by assessing tumor response after up to six cycles. Blood samples will be collected at specific times to check drug levels. The study also includes longer-term follow-up of about one to two years to observe ongoing effects and safety. Total participation duration depends on treatment response and continuation.
CONDITIONS
Brief Title
Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Adults 18 years of age or older
- ECOG performance status score of 2 or less
- Life expectancy of at least 12 weeks
- Histopathologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL)
- Presence of measurable disease
- Adequate bone marrow function and vital organ reserve
- Ability to comply with study procedures
- Use of adequate contraception during the trial
You will not qualify if you...
- Presence of unresolved drug-related adverse events greater than Grade 1
- Lymphoma involving the central nervous system
- Incomplete washout period for prior anti-tumor therapies
- Corticosteroid use not matching protocol requirements
- Recent or planned major surgery or trauma
- Recent vaccination with a live vaccine
- Inability to stop prohibited medications
- Need for immunosuppressive agents or biologics due to underlying disease
- Active infection
- Significant cardiovascular disease
- Gastrointestinal disease affecting drug intake or absorption
- History of other malignancies
- Known allergy to study drugs
- Other severe or uncontrolled systemic diseases
- Conflict of interest (e.g., site staff or sponsor employees)
- Pregnant or breastfeeding women
- Inability to comply with protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 21 days each
Participants receive GW5282 combined with Golidocitinib or the conventional CHOP regimen as part of their treatment for T-cell lymphoma. Treatment includes dose escalation and dose expansion phases with multiple 21-day cycles.
Visits for each cycle including dosing and assessments (approximately 6 cycles)
Duration - Approximately 1 to 2 years
Participants are monitored for efficacy and safety outcomes including adverse events and response to treatment for an average of 1 to 2 years after treatment completion.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 12 locations
1
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
2
Fujian Cancer Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
3
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Not Yet Recruiting
4
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
5
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
6
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Not Yet Recruiting
7
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
8
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Not Yet Recruiting
9
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Not Yet Recruiting
10
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
11
Shanxi Provincial Cancer Hospital
Taiyuan, China
Not Yet Recruiting
12
Henan Cancer Hospital
Zhengzhou, China
Not Yet Recruiting
Research Team
J
Jingrun Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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