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El ensayo clínico NCT07492628 (DUET-UC-NK) para Cáncer de vejiga, Carcinoma Urotelial, Carcinoma Urotelial Metastásico, Carcinoma Urotelial Localmente Avanzado, Carcinoma urotelial del tracto superior está reclutando. 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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Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma (DUET-UC-NK) Fase I 42 Primero en humanos
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07492628 (DUET-UC-NK) está diseñado para estudiar el tratamiento de Cáncer de vejiga, Carcinoma Urotelial, Carcinoma Urotelial Metastásico, Carcinoma Urotelial Localmente Avanzado, Carcinoma urotelial del tracto superior. Es un estudio intervencionista de Fase I. Su estado actual es: reclutando. El estudio se inició el 2 de marzo de 2026, con el objetivo de reclutar a 42 participantes. Dirigido por Beijing Biotech, se espera que finalice el 17 de mayo de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 25 de marzo de 2026.
Resumen
This hypothetical first-in-human study is designed to evaluate the safety, feasibility, and preliminary anti-tumor activity of an allogeneic dual-target Nectin-4/HER2 CAR-NK cell product in adults with relapsed/refractory locally advanced or metastatic urothelial carcinoma. Based on public urothelial-cancer evidence, Nectin-4 was selected as the lead antigen because it has the strongest disease-specific clinical vali...Mostrar más
Descripción detallada
Advanced urothelial carcinoma remains a high-unmet-need disease after platinum-based chemotherapy, PD-1/PD-L1 inhibition, and-where available-Nectin-4- or HER2-directed therapies. Public trial activity in urothelial cancer strongly supports Nectin-4 as the best validated anchor antigen, while HER2 identifies a clinically relevant and actionable subset. Because both antigens can be heterogeneous, this example protocol...Mostrar más
Título oficial
A Phase 1, Open-Label, Multicenter, Non-Randomized, Dose-Escalation and Dose-Expansion Study of Allogeneic Dual-Target Nectin-4/HER2 CAR-NK Cells Following Fludarabine/Cyclophosphamide Lymphodepletion in Adults With Relapsed/Refractory, Locally Advanced or Metastatic Urothelial Carcinoma
Condiciones médicas
Cáncer de vejigaCarcinoma UrotelialCarcinoma Urotelial MetastásicoCarcinoma Urotelial Localmente AvanzadoCarcinoma urotelial del tracto superiorOtros ID del estudio
- DUET-UC-NK
- EB-DT-NK-UC-105
Número del NCT
Inicio del estudio (real)
2026-03-02
Última actualización
2026-03-25
Fecha de finalización (estimada)
2028-05-17
Inscripción (prevista)
42
Tipo de estudio
Intervencionista
FASE
Fase I
Estado general
Reclutando
Palabras clave
CAR-NK
allogeneic NK cells
Nectin-4
HER2
ERBB2
urothelial carcinoma
bladder cancer
dual-target
lymphodepletion
solid tumor immunotherapy
EpCAM
RP2D
allogeneic NK cells
Nectin-4
HER2
ERBB2
urothelial carcinoma
bladder cancer
dual-target
lymphodepletion
solid tumor immunotherapy
EpCAM
RP2D
Objetivo principal
Tratamiento
Método de asignación
No aleatorizado
Modelo de intervención
Diseño secuencial
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalDose Escalation Participants receive lymphodepletion with cyclophosphamide and fludarabine followed by EB-DT-NK-UC101 IV infusions on Day 1 and Day 8 of a 21-day cycle. Planned dose levels: 1 × 10\^7, 3 × 10\^7, and 1 × 10\^8 CAR-NK cells/kg | EB-DT-NK-UC101 Allogeneic cord-blood-derived dual-target Nectin-4/HER2 CAR-NK cells with inducible caspase-9 safety switch. Cyclophosphamide Lymphodepleting chemotherapy given before the first CAR-NK infusion. Fludarabina Lymphodepleting chemotherapy given before the first CAR-NK infusion |
ExperimentalDose Expansion Participants receive the RP2D identified in Arm A using the same lymphodepletion backbone and infusion schedule. Expansion enriches for Nectin-4-positive disease and captures HER2 co-expression prospectively. | EB-DT-NK-UC101 Allogeneic cord-blood-derived dual-target Nectin-4/HER2 CAR-NK cells with inducible caspase-9 safety switch. Cyclophosphamide Lymphodepleting chemotherapy given before the first CAR-NK infusion. Fludarabina Lymphodepleting chemotherapy given before the first CAR-NK infusion |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Incidence of dose-limiting toxicities (DLTs) | 28 Days | |
Incidence and severity of treatment-emergent adverse | Incidence and severity of treatment-emergent adverse events graded by CTCAE v5.0,including CRS, ICANS, infusion reactions, GvHD, and organ-specific toxicities | 12 months |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Objective response rate (ORR) by RECIST v1.1 | 12 months | |
Disease control rate | 12 months | |
Duration of response | 24 months | |
Progression-free survival | 24 months | |
Overall survival | 24 months |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Age 18-75 years at consent.
- Histologically confirmed urothelial carcinoma of the bladder, ureter, renal pelvis, or urethra that is unresectable locally advanced or metastatic.
- Disease progression after, intolerance to, or ineligibility for standard therapy, including platinum-based chemotherapy and PD-1/PD-L1 blockade when appropriate for the patient and region. Prior enfortumab vedotin and prior HER2-directed therapy are allowed, but a fresh biopsy is strongly preferred after the latest systemic regimen.
- At least one measurable lesion per RECIST v1.1.
- Tumor tissue available for central review demonstrating Nectin-4 positivity (for example, IHC ≥1+ in ≥10% tumor cells) and HER2 status assessed by IHC/ISH. At least one of the selected therapeutic targets must be present; dose expansion preferentially enrolls Nectin-4-positive disease.
- ECOG performance status 0-1.
- Adequate bone marrow, hepatic, renal, and coagulation function.
- Life expectancy of at least 12 weeks.
- Negative pregnancy test for women of childbearing potential and agreement to use highly effective contraception during study treatment and follow-up as defined in the protocol.
- Ability to understand and sign informed consent.
- Active or untreated central nervous system metastases or leptomeningeal disease. Previously treated CNS disease is allowed if clinically stable and off escalating corticosteroids.
- Prior allogeneic hematopoietic stem cell transplant, prior solid-organ transplant, or active graft-versus-host disease.
- Clinically significant autoimmune disease requiring systemic immunosuppression within the defined washout window.
- Uncontrolled infection, including uncontrolled hepatitis B, hepatitis C, HIV, sepsis, or active tuberculosis.
- Clinically significant cardiac disease, active myocarditis, unstable angina, recent myocardial infarction, uncontrolled arrhythmia, or clinically meaningful decline in left ventricular ejection fraction that would increase risk from HER2-directed cell therapy.
- Clinically significant pulmonary disease (for example, uncontrolled interstitial lung disease or oxygen-dependent respiratory compromise).
- Use of systemic corticosteroids or other immunosuppressive medications above protocol-allowed limits within the washout window.
- History of severe hypersensitivity to fludarabine, cyclophosphamide, or cell-product excipients.
- Pregnancy or breastfeeding.
- Another active malignancy requiring systemic therapy or likely to interfere with protocol assessments, except for protocol-allowed low-risk cancers.
Beijing BiotechContactos centrales del estudio
Contacto: Seni S Lu, Phd, +86 13076790030, [email protected]
1 Centros del estudio en 1 países
Guangdong
Peking University Shenzhen Hospital, Shenzhen, Guangdong, 518036, China
Zhen J Peng, Phd, Contacto, +86 13076790039, [email protected]
Reclutando