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Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3) Phase 1, Phase 2 165 Randomisiert Dosis-Eskalation Offene Studie Kombinationstherapie

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Die klinische Studie NCT07496229 untersucht Behandlung im Zusammenhang mit T-cell Lymphomas. Diese interventionsstudie der Phase 1 Phase 2 hat den Status noch nicht rekrutierend. Der Start ist für 1. März 2026 geplant, bis 165 Teilnehmer aufgenommen werden. Durchgeführt von Dizal Pharmaceuticals wird der Abschluss für 1. Dezember 2029 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. März 2026 aktualisiert.
Kurzbeschreibung
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...Mehr anzeigen
Offizieller Titel

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

Erkrankungen
T-cell Lymphomas
Weitere Studien-IDs
  • GW2025EZ0002
NCT-Nummer
NCT07496229
Studienbeginn (tatsächlich)
2026-03
Zuletzt aktualisiert
2026-03-27
Studienende (vorauss.)
2029-12
Geplante Rekrutierung
165
Studientyp
Interventionsstudie
PHASE
Phase 1
Phase 2
Status
Noch nicht rekrutierend
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellDose 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.
ExperimentellDose expansion cohorts (Part B, randomized)
GW5282 combined with Golidocitinib
GW5282 and Golidocitinib will be administered at the doses determined during escalation part.
ExperimentellControl cohort (Part B, randomized)
Conventional CHOP regimen
CHOP regimen includes the administrations of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  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
Zentrale Studienkontakte
Kontakt: Jingrun Li, +86-21-61097800, [email protected]
12 Studienstandorte in 1 Ländern

Chongqing Municipality

Chongqing Cancer Hospital, Chongqing, Chongqing Municipality, China
Liu, Kontakt

Fujian

Fujian Cancer Hospital, Fuzhou, Fujian, China
He, Kontakt

Guangxi

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

Henan

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

Hubei

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

Jiangsu

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

Sichuan

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

Zhejiang

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