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Clinical Trial NCT07496229 for T-cell Lymphomas is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3) Phase 1, Phase 2 165 Randomized Dose Escalation Open-Label Combination Therapy

Not yet recruiting
Clinical Trial NCT07496229 is designed to study Treatment for T-cell Lymphomas. This Phase 1 Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on March 1, 2026 until the study accrues 165 participants. Led by Dizal Pharmaceuticals, this study is expected to complete by December 1, 2029. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
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 randomiz...Show More
Official Title

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

Conditions
T-cell Lymphomas
Other Study IDs
  • GW2025EZ0002
NCT ID Number
NCT07496229
Start Date (Actual)
2026-03
Last Update Posted
2026-03-27
Completion Date (Estimated)
2029-12
Enrollment (Estimated)
165
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalDose escalation cohorts (Part A, non-randomized)
GW5282 combined with Golidocitinib
GW5282 and Golidocitinib will be administered in combination as twice daily (BID) and once daily (QD), respectively. The starting dose will be GW5282 40 mg BID combined with golidocitinib 150 mg QD. If tolerated, the dose of GW5282 will be subsequently escalated.
ExperimentalDose expansion cohorts (Part B, randomized)
GW5282 combined with Golidocitinib
GW5282 and Golidocitinib will be administered at the doses determined during escalation part.
ExperimentalControl cohort (Part B, randomized)
Conventional CHOP regimen
CHOP regimen includes the administrations of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Part A: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
To evaluate the safety and tolerability of the combination of GW5282 and golidocitinib. Dose Limiting Toxicity (DLT) was evaluated in the DLT observation frame.
The DLT observation period is defined as the 21 days after the first dose.
Part B: Complete Response Rate (CRR) According to Lugano 2014 by Investigators' Review
To evaluate anti-tumor activity of GW5282 combined with golidocitinib as a chemo-free induction therapy for newly diagnosed PTCL, and compare it with conventional CHOP regimen.
Up to 6 cycles, each cycle is 21 days
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Part A: Plasma concentration of GW5282 and golidocitinib
To characterize the pharmacokinetics of GW5282 and golidocitinib when orally given together
C1D1, C1D15, and Day 1 of Cycle 2~9
Part A: Efficacy parameters
To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Objective Response Rate (ORR)
through the study completion, an average of around 1~2 years
Part A: Efficacy parameters
To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Complete Response Rate (CRR)
through the study completion, an average of around 1~2 years
Part A: Efficacy parameters
To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Duration of Response (DoR)
through the study completion, an average of around 1~2 years
Part A: Efficacy parameters
To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: Progression Free Survival (PFS)
through the study completion, an average of around 1~2 years
Part B: Other efficacy parameters
To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: ORR
through the study completion, an average of around 1~2 years
Part B: Other efficacy parameters
To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoint: DoR
through the study completion, an average of around 1~2 years
Part B: Other efficacy parameters
To assess anti-tumor efficacy of GW5282 combined with golidocitinib using endpoints: PFS.
through the study completion, an average of around 1~2 years
Part B: Adverse Events (AEs) / Serious Adverse Events (SAEs)
To determine the safety and tolerability of GW5282 combined with golidocitinib: Number of Participants With AEs, Number of Participants With SAEs. Using investigator reported AEs according to CTCAE and SAE criteria.
through the study completion, an average of around 1~2 years
Part B: Plasma concentration of GW5282 and golidocitinib
To characterize the pharmacokinetics of GW5282 and golidocitinib when orally given together
C1D1, C1D15, and Day 1 of subsequent cycles till treatment discontinuation
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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.
Dizal Pharmaceuticals logoDizal Pharmaceuticals
Study Central Contact
Contact: Jingrun Li, +86-21-61097800, [email protected]
12 Study Locations in 1 Countries

Chongqing Municipality

Chongqing Cancer Hospital, Chongqing, Chongqing Municipality, China
Liu, Contact

Fujian

Fujian Cancer Hospital, Fuzhou, Fujian, China
He, Contact

Guangxi

Guangxi Medical University Cancer Hospital, Nanning, Guangxi, China
Cen, Contact

Henan

Henan Provincial People's Hospital, Zhengzhou, Henan, China
Zhu, Contact

Hubei

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Zhang, Contact

Jiangsu

Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
Xu, Contact

Sichuan

West China Hospital of Sichuan University, Chengdu, Sichuan, China
Zou, Contact

Zhejiang

Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, China
Guo, Contact
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Shen, Contact
Fudan University Shanghai Cancer Center, Shanghai, China
Tao, Contact
Shanxi Provincial Cancer Hospital, Taiyuan, China
Su, Contact
Henan Cancer Hospital, Zhengzhou, China
Zhou, Contact