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

NCT07496229 | Recruiting Phase 1

• 1 other identifier: GW2025EZ0002
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 12

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.

Conditions

T-cell Lymphomas

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Part A: Plasma concentration of GW5282 and golidocitinib

  C1D1, C1D15, and Day 1 of Cycle 2~9

• Part A: Efficacy parameters

  through the study completion, an average of around 1~2 years

• Part A: Efficacy parameters

  through the study completion, an average of around 1~2 years

• Part A: Efficacy parameters

  through the study completion, an average of around 1~2 years

• Part A: Efficacy parameters

  through the study completion, an average of around 1~2 years

Study Arms (3)

Dose escalation cohorts (Part A, non-randomized)

EXPERIMENTAL

Drug: GW5282 combined with Golidocitinib

Dose expansion cohorts (Part B, randomized)

EXPERIMENTAL

Drug: GW5282 combined with Golidocitinib

Control cohort (Part B, randomized)

EXPERIMENTAL

Drug: Conventional CHOP regimen

Interventions

GW5282 combined with Golidocitinib DRUG

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.

Dose escalation cohorts (Part A, non-randomized)

Conventional CHOP regimen DRUG

CHOP regimen includes the administrations of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.

Control cohort (Part B, randomized)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent;
• Adult ≥ 18 years of age;
• ECOG performance status score ≤ 2;
• Life expectancy of not less than 12 weeks;
• Histopathologically confirmed diagnosis of PTCL;
• Presence of measurable disease;
• Adequate bone marrow function and vital organ function reserve;
• Ability to comply with study requirements and to complete study-related procedures;
• Adequate contraception during participation in the trial.

You may not qualify if:

• Presence of unresolved drug-related adverse events greater than Grade 1;
• Lymphoma involving the central nervous system;
• Failure to complete the required washout period for other anti-tumor therapies;
• Corticosteroid use that does not meet protocol requirements;
• Major surgery/trauma within a short period, or planned major surgery within a short period;
• Vaccination with a live vaccine within a short period;
• Inability to discontinue prohibited medications;
• Requirement for immunosuppressive agents or biologics due to an underlying disease;
• Presence of active infection;
• Significant cardiovascular disease;
• Presence of gastrointestinal disease that might affect drug intake or absorption;
• History of other malignancies;
• Known allergy to the study drug;
• Other severe or uncontrolled systemic diseases;
• Personnel with a conflict of interest (e.g., site staff, sponsor employees);

Sponsors & Collaborators

• Dizal Pharmaceuticals: lead

Study Sites (12)

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

MeSH Terms

Conditions

Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Jingrun Li

CONTACT

+86-21-61097800; jingrun.li@dizalpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 27, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CN (12)