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הניסוי הקליני NCT07496229 עבור T-cell Lymphomas הוא טרם החל גיוס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן.
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תצוגת כרטיסים
חזרה לחיפוש

Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3) שלב I, שלב II 165 אקראי העלאת מינון תווית פתוחה טיפול משולב

טרם החל גיוס
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07496229 מתוכנן לבדוק את טיפול עבור T-cell Lymphomas. זהו מחקר שלב I שלב II מסוג התערבותי שנמצא במצב טרם החל גיוס. גיוס המשתתפים צפוי להתחיל ב-1 במרץ 2026, במטרה לכלול 165 משתתפים. המחקר ינוהל על ידי Dizal Pharmaceuticals וצפוי להסתיים ב-1 בדצמבר 2029. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-27 במרץ 2026.
סיכום קצר
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...הצג עוד
כותרת רשמית

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

מצבים רפואיים
T-cell Lymphomas
מזהי מחקר נוספים
  • GW2025EZ0002
מספר NCT
NCT07496229
תחילת המחקר (בפועל)
2026-03
עדכון אחרון שפורסם
2026-03-27
סיום המחקר (מוערך)
2029-12
משתתפים (מתוכנן)
165
סוג המחקר
התערבותי
שלב
שלב I
שלב II
סטטוס
טרם החל גיוס
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצה יחידה
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
ניסיDose 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.
ניסיDose expansion cohorts (Part B, randomized)
GW5282 combined with Golidocitinib
GW5282 and Golidocitinib will be administered at the doses determined during escalation part.
ניסיControl cohort (Part B, randomized)
Conventional CHOP regimen
CHOP regimen includes the administrations of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.
מדדי תוצאה ראשיים
מדד תוצאהתיאור המדידהטווח זמן
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
מדדי תוצאה משניים
מדד תוצאהתיאור המדידהטווח זמן
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
עוזר השתתפות
קריטריוני זכאות

גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
  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
איש קשר מרכזי למחקר
איש קשר: Jingrun Li, +86-21-61097800, [email protected]
12 מיקומי המחקר ב-1 מדינות

Chongqing Municipality

Chongqing Cancer Hospital, Chongqing, Chongqing Municipality, China
Liu, איש קשר

Fujian

Fujian Cancer Hospital, Fuzhou, Fujian, China
He, איש קשר

Guangxi

Guangxi Medical University Cancer Hospital, Nanning, Guangxi, China
Cen, איש קשר

Henan

Henan Provincial People's Hospital, Zhengzhou, Henan, China
Zhu, איש קשר

Hubei

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

Jiangsu

Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
Xu, איש קשר

Sichuan

West China Hospital of Sichuan University, Chengdu, Sichuan, China
Zou, איש קשר

Zhejiang

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