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Ensayo de la seguridad y la eficacia de las combinaciones de JCAR017 en sujetos con neoplasias malignas de células B recidivantes o resistentes al tratamiento (PLATFORM) - JCAR017-BCM-002

Actualizada: 28 abril, 2021   |   ClinicalTrials.gov

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Detalles del estudio

  • Fase I/Fase II

    Fase

  • Géneros

  • 18+

    Rango de edad

  • 6

    Ubicación (es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Arm E: JCAR017 in combination with relatlimab and/or nivolumab
Tratamiento biológico: JCAR017 Drug: Nivolumab Drug: Relatlimab
Experimental: Arm F: JCAR017 in combination with CC-99282
Tratamiento biológico: JCAR017 Drug: CC-99282
En investigación: Grupo A: JCAR017 en combinación con durvalumab
Fármaco: Durvalumab Tratamiento biológico: JCAR017
En investigación: Grupo B: JCAR017 en combinación con CC-122
Fármaco: CC-122 Tratamiento biológico: JCAR017
En investigación: Grupo C: JCAR017 en combinación con CC-220
Fármaco: CC-220 Tratamiento biológico: JCAR017
En investigación: Grupo D: JCAR017 en combinación con ibrutinib
Fármaco: Ibrutinib Tratamiento biológico: JCAR017

Criterios clave de elegibilidad

Criterios de inclusión: 1. El sujeto tiene ≥ 18 años de edad en el momento de firmar el formulario de consentimiento informado (). 2. El sujeto debe comprender y firmar voluntariamente un FCI antes de que se realice cualquier evaluación o procedimiento relacionado con el estudio. 3. El sujeto está dispuesto y puede cumplir el calendario de visitas del estudio y otros requisitos del protocolo. 4. El sujeto debe tener LNH de células B agresivo histológicamente confirmado en la última recidiva de acuerdo con "The 2016 revision of the WHO classification of lymphoid neoplasms" defined as: 1. Diffuse large B-cell lymphoma (DLBCL) Not otherwise specified (NOS) including transformed indolent Non-Hodgkin lymphoma (NHL) 2. Follicular lymphoma Grade 3B 3. T cell/histiocyte-rich large B-cell lymphoma 4. Epstein-Barr virus (EBV) positive DLBCL, NOS 5. Primary mediastinal (thymic) large B-cell lymphoma 6. High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma) 5. Subjects disease must have relapsed or be refractory to at least 2 prior lines of therapy. Previous therapy must have included a CD20-targeted agent and an anthracycline. 6. Subject must have 1. Positron emission tomography (PET)-positive and computed tomography (CT) measurable disease as per Lugano Classification 2. Serum lactate dehydrogenase (LDH) ≥ 500 U/L and/or sum of product of perpendicular diameters (SPD) of index lesions ≥ 50 cm² by CT scan (Phase 1 of Arms C and D only) 7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 at screening 8. Adequate organ function 9. Subjects must agree to not donate blood, organs, sperm or semen, and egg cells for usage in other individuals 10. Participants must agree to use effective contraception Exclusion Criteria: 1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study based on investigator´s judgment. 2. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study based on investigator´s judgment. 3. Subject has any condition that confounds the ability to interpret data from the study based on investigator´s judgment. 4. Subjects with prior history of malignancies, other than aggressive R/R NHL, unless the subject has been free of the disease for ≥ 2 years with the exception of the following non-invasive malignancies: - Basal cell carcinoma of the skin - Squamous cell carcinoma of the skin - Carcinoma in situ of the cervix - Carcinoma in situ of the breast - Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative. - Other completely resected stage 1 solid tumor with low risk for recurrence 5. Prior treatment with any prior gene therap y product 6. Prior treatment with any adoptive T cell therapy; prior hematopoietic stem cell transplant (HSCT) is allowed 7. Allogeneic HSCT within 90 days of leukapheresis 8. Prior treatment with anti PD-1 or PD-L1 therapy (Arm A) - Anti PD-1 or PD-L1 (Arm A) - CC-122 (Arm B) - CC-220 (Arm C) - Prior treatment with ibrutinib is not exclusionary for subjects on any study arm 9. Presence of acute or chronic graft-versus-host disease (GVHD) 10. History of or active hepatitis B or hepatitis C or human immunodeficiency virus (HIV) infection 11. Uncontrolled bacterial, viral or fungal infection at the time of leukapheresis, lymphodepleting chemotherapy or JCAR017 infusion 12. History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease 13. History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis 14. Subjects with active CNS or cerebrospinal fluid (CSF) involvement by malignancy 15. Pregnant or nursing (lactating) women. 16. Subjects with active auto immune disorders/processes or active neurological or inflammatory disorders

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Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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