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Recruiting

A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies (PLATFORM) - JCAR017-BCM-002

Actualizada: 30 septiembre, 2020   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1/Phase 2

    Fase

  • Géneros

  • 18+

    Rango de edad

  • 6

    Ubicación (es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Arm A: JCAR017 in combination with Durvalumab
Drug: Durvalumab Biological: JCAR017
Experimental: Arm B: JCAR017 in combination with CC-122
Drug: CC-122 Biological: JCAR017
Experimental: Arm C: JCAR017 in combination with CC-220
Drug: CC-220 Biological: JCAR017
Experimental: Arm D: JCAR017 in combination with Ibrutinib
Drug: Ibrutinib Biological: JCAR017

Criterios clave de elegibilidad

Inclusion Criteria: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (). 2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements. 4. Subject must have histologically confirmed at last relapse aggressive B-cell NHL according to "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

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
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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