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A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Combination with Atezolizumab in Subjects with Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Not Enrolling

Trial ID:NCT02926833

View complete trial on ClinicalTrials.gov

Protocol #:16-436

DiseasesNon-Hodgkin's Lymphoma

Phase:I/II

Principal Investigator:Jacobson, Caron, A

Trial Description:
This is a phase 1-2, open-label study in subjects with refractory DLBCL, evaluating the safety and efficacy of axicabtagene ciloleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T cell therapy, in combination with atezolizumab, a humanized, monoclonal antibody that binds to PD-L1 and blocks interaction with the PD-1 and B7.1 receptors. The trial will be separated into two distinct phases designated as phase 1 and phase 2.

Eligibilty Requirements:
Histologically confirmed:

Diffuse Large B Cell Lymphoma (DLBCL)

Chemotherapy-refractory disease, defined as one or more of the following:

Stable disease (duration of stable disease must be less than or equal to 6 months) or progressive disease as best response to most recent chemotherapy containing regimen

Disease progression or recurrence less than or equal to 12 months of prior autologous SCT

Subjects must have received adequate prior therapy including at a minimum:

anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative and

an anthracycline containing chemotherapy regimen

At least one measurable lesion per revised IWG Response Criteria

Age 18 or older

Eastern cooperative oncology group (ECOG) performance status of 0 or 1

Adequate organ and bone marrow function

All subjects or legally appointed representatives/caregivers, must personally sign and date the IRB/IEC approved consent form before initiating any study specific procedures or activities.

History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years

History of allogeneic stem cell transplantation

Prior CAR therapy or other genetically modified T cell therapy

Clinically significant active infection

Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)

Subjects with detectable cerebrospinal fluid malignant cells or brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases

History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement

History of autoimmune disease. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study.

History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest CT scan at screening. History of radiation pneumonitis in the radiation field (fibrosis) is allowed.

Prior treatment with PD-L1 inhibitor, PD-1 inhibitor, anti-CTLA4, anti-CD137, anti-OX40 or other immune checkpoint blockade or activator therapy with the exception of subjects who received atezolizumab in this study and are eligible for re-treatment

Prior CD19 targeted therapy