Trial Search Results
Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Adults With Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
The sponsors are testing an investigational treatment including two experimental drugs named KTE-C19 and Atezolizumab. The main purpose of this research study is to determine if the investigational products, KTE-C19 and Atezolizumab, when used concurrently and administered after participants receive a 3 day course of chemotherapy, is safe and effective in treating non-Hodgkin B-cell lymphoma and standard therapies available to treat the disease have not been effective.
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
Kite, A Gilead Company
Collaborator: Genentech, Inc.
Stanford Investigator(s):
Intervention(s):
- Biological: KTE-C19
- Biological: Atezolizumab
- Drug: Cyclophosphamide
- Drug: Fludarabine
Phase:
Phase 1/Phase 2
Eligibility
Key Inclusion Criteria:
1. Histologically confirmed 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 stem cell transplantation (SCT)
3. Individuals 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 International Working Group (IWG) Response
Criteria
5. Age 18 years or older
6. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
7. Adequate organ and bone marrow function
8. All individuals or legally appointed representatives/caregivers, must personally sign
and date the institutional review board (IRB)/independent ethics committee (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. Individuals 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 central nervous system (CNS)
involvement
8. History of autoimmune disease. Participants with a history of autoimmune-related
hypothyroidism on a stable dose of thyroid replacement hormone and participants 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 computed tomography (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 Individuals who received atezolizumab in this study and are eligible for
re-treatment
11. Prior CD19 targeted therapy
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting