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El ensayo clínico NCT07496229 para T-cell Lymphomas está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3) Fase I, Fase II 165 Aleatorizado Escalada de dosis Etiqueta abierta Terapia combinada

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El ensayo clínico NCT07496229 está diseñado para estudiar el tratamiento de T-cell Lymphomas. Este es un estudio intervencionista de Fase I Fase II. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de marzo de 2026 hasta completar 165 participantes. Dirigido por Dizal Pharmaceuticals, se espera que finalice el 1 de diciembre de 2029. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de marzo de 2026.
Resumen
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...Mostrar más
Título oficial

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

Condiciones médicas
T-cell Lymphomas
Otros ID del estudio
  • GW2025EZ0002
Número del NCT
NCT07496229
Inicio del estudio (real)
2026-03
Última actualización
2026-03-27
Fecha de finalización (estimada)
2029-12
Inscripción (prevista)
165
Tipo de estudio
Intervencionista
FASE
Fase I
Fase II
Estado general
Aún no recluta
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
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.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  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
Contactos centrales del estudio
Contacto: Jingrun Li, +86-21-61097800, [email protected]
12 Centros del estudio en 1 países

Chongqing Municipality

Chongqing Cancer Hospital, Chongqing, Chongqing Municipality, China
Liu, Contacto

Fujian

Fujian Cancer Hospital, Fuzhou, Fujian, China
He, Contacto

Guangxi

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

Henan

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

Hubei

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

Jiangsu

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

Sichuan

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

Zhejiang

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