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El ensayo clínico NCT07480954 (DUAL-OV-CAR-NK) para Cáncer Epitelial de Ovario, Carcinoma Peritoneal Primario, Carcinoma de Trompa de Falopio, Recurrent or Refractory Disease After Standard Therapies 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-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16) (DUAL-OV-CAR-NK) Fase I, Fase II 36
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 NCT07480954 (DUAL-OV-CAR-NK) está diseñado para estudiar el tratamiento de Cáncer Epitelial de Ovario, Carcinoma Peritoneal Primario, Carcinoma de Trompa de Falopio, Recurrent or Refractory Disease After Standard Therapies. Es un estudio intervencionista de Fase I Fase II. Su estado actual es: reclutando. El estudio se inició el 4 de febrero de 2026, con el objetivo de reclutar a 36 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 18 de marzo de 2026.
Resumen
This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of dual-targeting chimeric antigen receptor natural killer (CAR-NK) cells in participants with recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer. At screening, each participant's tumor is assessed for expression of Mesothelin (MSLN), Folate Receptor alpha (FRalpha/FOLR1), and MUC16 (CA 1...Mostrar más
Descripción detallada
The study has two parts: (1) dose escalation using a standard 3+3 design within each antigen-pair cohort to determine safety and a recommended Phase 2 dose (RP2D), and (2) dose expansion at the RP2D to explore preliminary efficacy and translational biomarkers. Target selection (biomarker assignment): Tumor tissue (archival or fresh biopsy) is evaluated by immunohistochemistry (IHC) and/or flow cytometry for MSLN, FRa...Mostrar más
Título oficial
A Phase 1/2, Open-Label, Biomarker-Assigned Study of Dual-Targeting CAR-NK Cells Directed Against Mesothelin (MSLN), Folate Receptor Alpha (FRα/FOLR1), and/or MUC16 (CA125) in Patients With Recurrent or Refractory High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Condiciones médicas
Cáncer Epitelial de OvarioCarcinoma Peritoneal PrimarioCarcinoma de Trompa de FalopioRecurrent or Refractory Disease After Standard TherapiesOtros ID del estudio
- DUAL-OV-CAR-NK
- EB-CARNK-OV-101
Número del NCT
Inicio del estudio (real)
2026-02-04
Última actualización
2026-03-18
Fecha de finalización (estimada)
2028-05-17
Inscripción (prevista)
36
Tipo de estudio
Intervencionista
FASE
Fase I
Fase II
Fase II
Estado general
Reclutando
Palabras clave
CAR-NK
Dual targeting
Mesothelin (MSLN)
Folate Receptor alpha
MUC16 (CA 125)
Intraperitoneal administration
Adoptive cell therapy
Ovarian cancer
Dual targeting
Mesothelin (MSLN)
Folate Receptor alpha
MUC16 (CA 125)
Intraperitoneal administration
Adoptive cell therapy
Ovarian cancer
Objetivo principal
Tratamiento
Método de asignación
No aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalEB-NK-MF (MSLN/FRalpha) Dual-target CAR-NK cells recognizing Mesothelin (MSLN) and Folate Receptor alpha (FRalpha/FOLR1). Assigned to participants whose tumors express MSLN and FRalpha above threshold. | Dual-target CAR-NK cell product (Arm-specific) Quimioterapia linfodepletiva (cyclophosphamide and fludarabine) Standard supportive care antimicrobial prophylaxis per institutional practice |
ExperimentalEB-NK-MM (MSLN/MUC16) Dual-target CAR-NK cells recognizing Mesothelin (MSLN) and MUC16 (CA 125). Assigned to participants whose tumors express MSLN and MUC16 above threshold. | Dual-target CAR-NK cell product (Arm-specific) Quimioterapia linfodepletiva (cyclophosphamide and fludarabine) Standard supportive care antimicrobial prophylaxis per institutional practice |
ExperimentalEB-NK-FM (FRalpha/MUC16) Dual-target CAR-NK cells recognizing FRalpha (FOLR1) and MUC16 (CA 125). Assigned to participants whose tumors express FRalpha and MUC16 above threshold. | Dual-target CAR-NK cell product (Arm-specific) Quimioterapia linfodepletiva (cyclophosphamide and fludarabine) Standard supportive care antimicrobial prophylaxis per institutional practice |
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 events | Incidence and severity of treatment-emergent adverse events (TEAEs) graded by CTCAE v5.0 (including CRS and ICANS) | 12 months |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Objective response rate (ORR) | Objective response rate (ORR) by RECIST v1.1 (CR + PR) | 6 months |
Duration of response (DOR) among responders | 12 months | |
Progression-free survival (PFS) | 12 months | |
Overall survival (OS) | 24 months |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Mujer
- Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (high-grade serous preferred).
- Recurrent or refractory disease after at least 2 prior systemic treatment lines (including a platinum-based regimen unless contraindicated).
- Measurable disease per RECIST v1.1.
- Tumor expresses at least two of the following targets above protocol-defined threshold: MSLN, FRalpha (FOLR1), MUC16 (CA 125) (archival or fresh biopsy).
- ECOG performance status 0-1.
- Adequate organ function (example): ANC >= 1.0 x 10^9/L; platelets >= 75 x 10^9/L; hemoglobin >= 8 g/dL; AST/ALT <= 3 x ULN (<= 5 x ULN with liver metastases); total bilirubin <= 1.5 x ULN; creatinine clearance >= 50 mL/min.
- Negative pregnancy test for women of childbearing potential; agreement to use effective contraception through 12 months post-infusion (or per local gene-therapy guidance).
- Able to comply with study procedures and follow-up schedule; written informed consent.
- Prior gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within 6 months (or any prior therapy directed to the same target, per protocol).
- Active central nervous system (CNS) metastases or carcinomatous meningitis requiring therapy.
- Uncontrolled infection, including active tuberculosis; or clinically significant, uncontrolled viral infection.
- Known HIV infection with uncontrolled viremia; active hepatitis B or hepatitis C with detectable viral load (testing required at screening).
- Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, NYHA Class III/IV heart failure).
- Active autoimmune disease requiring systemic immunosuppression within 30 days (physiologic steroid replacement allowed).
- Concurrent anti-cancer therapy (chemotherapy, targeted therapy, radiotherapy) not permitted within a protocol-defined washout period.
- Major surgery within 4 weeks prior to lymphodepletion (except minor procedures).
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, +8613076790039, [email protected]
Reclutando