A Study of Armored CAR T Cells in People With Cancer
31 de agosto de 2026 actualizado por: Memorial Sloan Kettering Cancer Center
A Phase I Trial for R/R MetAstatic DLL3+ Cancers Utilizing Armored CAR T Cells (ARMADA)
The purpose of this study is to test the safety of DLL3-SAVVYZ-IL18 in people with DLL3+ cancer.
Descripción general del estudio
Estado
Estado
Reclutamiento
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
Inscripción
16
Fase
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: Adam Schoenfeld, MD
- Número de teléfono: 646-608-4042
- Correo electrónico: schoenfa@mskcc.org
Copia de seguridad de contactos de estudio
- Nombre: Ritesh Kotecha, MD
- Número de teléfono: 646-422-4791
- Correo electrónico: kotechar@mskcc.org
Ubicaciones de estudio
-
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New Jersey
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Basking Ridge, New Jersey, Estados Unidos, 07920
- Reclutamiento
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
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Contacto:
- Adam Schoenfeld, MD
- Número de teléfono: 646-608-4042
- Correo electrónico: schoenfa@mskcc.org
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Middletown, New Jersey, Estados Unidos, 07748
- Reclutamiento
- Memorial Sloan Kettering Monmouth (Limited protocol activities)
-
Contacto:
- Adam Schoenfeld, MD
- Número de teléfono: 646-608-4042
- Correo electrónico: schoenfa@mskcc.org
-
Montvale, New Jersey, Estados Unidos, 07645
- Reclutamiento
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
-
Contacto:
- Adam Schoenfeld, MD
- Número de teléfono: 646-608-4042
- Correo electrónico: schoenfa@mskcc.org
-
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New York
-
Commack, New York, Estados Unidos, 11725
- Reclutamiento
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
-
Contacto:
- Adam Schoenfeld, MD
- Número de teléfono: 646-608-4042
- Correo electrónico: schoenfa@mskcc.org
-
Harrison, New York, Estados Unidos, 10604
- Reclutamiento
- Memorial Sloan Kettering Westchester (Limited protocol activities)
-
Contacto:
- Adam Schoenfeld, MD
- Número de teléfono: 646-608-4042
- Correo electrónico: schoenfa@mskcc.org
-
New York, New York, Estados Unidos, 10065
- Reclutamiento
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
-
Contacto:
- Adam Schoenfeld, MD
- Número de teléfono: 646-608-4042
- Correo electrónico: schoenfa@mskcc.org
-
Uniondale, New York, Estados Unidos, 11553
- Reclutamiento
- Memorial Sloan Kettering Cancer Center @ Nassau (Limited Protocol Activities)
-
Contacto:
- Adam Schoenfeld, MD
- Número de teléfono: 646-608-4042
- Correo electrónico: schoenfa@mskcc.org
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
Participant Inclusion: Collection of T cells (Part A)
History of DLL3+ neuroendocrine tumors
- Includes patients with histologically confirmed SCLC, as well other advanced neuroendocrine tumors (NETs), including large cell neuroendocrine carcinomas (LCNECs), gastroenteropancreatic NETs (GEP-NETs), laryngeal NETs, genitourinary (GU) tract NETs, neuroendocrine prostate cancers (NEPCs), gynecological tract NETs, neuroblastomas, salivary NETs, skin NETs, NETs of unknown primary, or other tumor confirmed positive for DLL3 by IHC
- Any disease status is eligible for collection.
- DLL3 expression detected by IHC using archival tumor tissue or tissue obtained from a biopsy performed as part of standard clinical care. No new biopsy will be performed solely for DLL3 IHC eligibility testing.
- Off any immunosuppressive agents for 14 days prior to collection (physiologic dose of corticosteroids is acceptable)
Participant Inclusion: Treatment with DLL3-SAVVYZ-IL18 CAR T cells (Part B)
- Any participant with histologically confirmed SCLC or DLL3 positive tumor who has had one line of approved systemic therapy for limited or extensive stage disease and has progressed or is no longer deriving benefit or standard treatment is no longer tolerable or declines further standard treatment.
- Prior treatment should include an approved platinum-based regimen with/without ICI therapy if applicable to their disease.
- Other advanced tumors are eligible if there is documented progression and/or relapse after appropriate frontline treatment(s) and otherwise meet eligibility criteria.
- At least 1 measurable lesion as defined per modified RECIST 1.1 within 21 days prior to first dose of LDC.
- Age > 18 years old at the time of signing the informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Minimum life expectancy of 12 weeks.
- Participants previously treated with DLL3-specific therapies (i.e. antibody-drug conjugates, T-cell engager molecules) are permitted.
- History of CNS metastatic disease is permitted if previously treated and stable, defined as no evidence of radiographic progression for at least 4 weeks prior to the first dose of LDC, with any neurologic symptoms returned to baseline. Asymptomatic CNS metastatic disease must also be radiographically stable for at least 4 weeks prior to the first dose of LDC.
Adequate organ function is required, defined as follows:
- Hematologic: Hgb > 9 g/dL, platelets > 75 x103/ul
- Hepatic: Serum total bilirubin ≤1.5 mg/dL (unless Gilbert's syndrome), albumin > 3 g/dL.
- Hepatic: ALT and AST < 5 times the upper limit of normal unless thought to be disease-related.
- Renal: serum creatinine < 2.0 mg/dL (> 18 years) or ≤ 2.5 x institutional upper limit of normal (ULN) for age
- If serum creatinine is outside the normal range, then CrCl > 40 mL/min/1.73m2 (calculated or estimated) or GFR (mL/min/1.73m2) > 40% of predicted normal for age.
- Cardiac: LVEF ≥ 50% by resting echocardiogram
- Pulmonary: Adequate pulmonary function as assessed by ≥ 92% oxygen saturation on room air by pulse oximetry
Exclusion Criteria:
Participant Exclusion: Collection of T cells (Part A)
- Pregnant or lactating female participants; female participants of reproductive potential, unless they agree to use a highly effective method of contraception or abstain from heterosexual intercourse while receiving study treatment and for at least 12 months after all treatment is finished.
- Sexually active male participants with female partners of reproductive potential, unless they agree to use a condom during intercourse and their female partners use a highly effective method of contraception while the participant is receiving study treatment and for at least 12 months after all treatment is finished.
- Primary CNS malignancies, including glioblastoma multiforme (GBM), are excluded.
- Any systemic anti-cancer therapy within 14 days or at least 4 half lives prior to time of T cell collection, whichever is shorter.
- Radiation therapy completed within 7 days prior to time of T cell collection.
- Uncontrolled, symptomatic, intercurrent infection
Patients with following cardiac conditions will be excluded:
- New York Heart Association (NYHA) stage III or IV congestive heart failure.
- Myocardial infarction ≤ 6 months prior to enrollment.
- Positive serologic test results for HIV.
- Patients with active hepatitis B infection (as manifested by either detectable hepatitis B virus DNA by PCR and/or positivity for hepatitis B surface antigen)
- Patients with active hepatitis C infection (as manifested by detectable hepatitis C virus RNA by PCR)
Participant Exclusion: Treatment with DLL3-SAVVYZ-IL18 CAR T cells (Part B)
For prior immune related adverse events (irAEs):
- Unresolved pneumonitis of any grade or history of any grade ICI-mediated CNS toxicities
- Other unresolved toxicity grade 2 or higher, excluding hypothyroidism.
Any autoimmune disease requiring active systemic immunosuppression.
- Use of physiologic steroid replacement for adrenal insufficiency and inhaled corticosteroids are permitted
- Pregnant or lactating female participants; female participants of reproductive potential, unless they agree to use a highly effective method of contraception or abstain from heterosexual intercourse while receiving study treatment and for at least 12 months after all treatment is finished.
- Sexually active male participants with female partners of reproductive potential, unless they agree to use a condom during intercourse and their female partners use a highly effective method of contraception while the participant is receiving study treatment and for at least 12 months after all treatment is finished.
- Primary CNS malignancies, including glioblastoma multiforme (GBM), are excluded
- CNS metastatic disease that is symptomatic (including use of steroids within 7 days prior to the first dose of LDC) or new/enlarging is excluded. Patients with treated brain metastases are permitted if treatment was completed at least 4 weeks prior to the first dose of LDC and the disease has remained radiographically stable for at least 4 weeks prior to the first dose of LDC, with neurologic symptoms returned to baseline.
- Uncontrolled, symptomatic, intercurrent infection
- Patient/parent/guardian unable to give informed consent.
- Any other condition/issue which, in the opinion of the treating physician, would make the patient ineligible for the study; conditions that in the Principal Investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
3
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Experimental: Dose Level 1
This is the starting dose of DLL3-SAVVYZ-IL18 CAR T cell Dose
|
DLL3-SAVVYZ-IL18 CAR T cell
|
|
Experimental: Dose Level 2
Eligible participants will receive DLL3-SAVVYZ-IL18 CAR T cell Dose at this Dose Level if no Dose Limiting Toxicities are experienced at Dose Level 1
|
DLL3-SAVVYZ-IL18 CAR T cell
|
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Experimental: Dose Level -1
Eligible participants will receive DLL3-SAVVYZ-IL18 CAR T cell Dose at this Dose Level if Dose Limiting Toxicities are experienced at Dose Level 1
|
DLL3-SAVVYZ-IL18 CAR T cell
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximum Tolerated Dose/MTD of DLL3-SAVVYZ-IL18 CAR T cell
Periodo de tiempo: up to 1 year
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The objective of the dose-escalation phase is to determine the MTD of this dose-escalation schedule.
The MTD will be defined as the dose at which the toxicity rate does not exceed an acceptable threshold of toxicity, assumed at 25% in this study.
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up to 1 year
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Adam Schoenfeld, MD, Memorial Sloan Kettering Cancer Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
28 de agosto de 2026
Finalización primaria (Estimado)
Finalización primaria
28 de agosto de 2029
Finalización del estudio (Estimado)
Finalización del estudio
28 de agosto de 2029
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
20 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
20 de agosto de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
24 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
2 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
31 de agosto de 2026
Última verificación
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Neoplasias por tipo histológico
- Enfermedades pulmonares
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Neoplasias Pulmonares
- Carcinoma
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Tumores neuroendocrinos
- Carcinoma de pulmón de células pequeñas
- Carcinoma Neuroendocrino
Otros números de identificación del estudio
Otros números de identificación del estudio
- 26-062
- 1R01CA303470-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials.
The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov
when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required.
Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later.
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals.
Requests may be made to: crdatashare@mskcc.org.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .