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A Study Evaluating KTE-C19 in Combination With Atezolizumab in Subjects With Refractory Diffuse Large B-Cell Lymphoma (DLBCL)


Trial ID:NCT02926833

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Protocol #:16-436


Principal Investigator:Caron Jacobson. M.D

Trial Description:
This is a phase 1-2, open-label study in subjects with refractory DLBCL, evaluating the safety and efficacy of KTE-C19, 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.

Kathleen McDermott, Dana-Farber Cancer Institute,

Conducting Institutions:
Dana-Farber Cancer Institute
Brigham and Women's Hospital

Eligibilty Requirements:
Key Inclusion Criteria:

1. Histologically confirmed:

- Diffuse Large B Cell Lymphoma (DLBCL)

2. 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

3. 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

4. At least one measurable lesion per revised IWG Response Criteria

5. Age 18 or older

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

7. Adequate organ and bone marrow function

8. 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.

Key Exclusion Criteria:

1. 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

2. History of allogeneic stem cell transplantation

3. Prior CAR therapy or other genetically modified T cell therapy

4. Clinically significant active infection

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

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

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

8. 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.

9. 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.

10. 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

11. Prior CD19 targeted therapy