OVERVIEW
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) (ZUMA-6)
PROTOCOL SUMMARY
The primary objective of phase 1 is to evaluate the safety of KTE-C19 and atezolizumab combination regimens. The primary objective of phase 2 is to evaluate the efficacy of KTE-C19 and atezolizumab, as measured by complete response rate in participants with refractory diffuse large B-cell lymphoma (DLBCL). Participants who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968 (NCT05041309).
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Refractory Diffuse Large B Cell Lymphoma
Gender
N/A
Date
September 2016 - January 2023
Study Type
Interventional
Study Phase
Phase 1, Phase 2
Product
KTE-C19, Atezolizumab, Cyclophosphamide, Fludarabine
Eligibility information
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-cluster of differentiate 20 (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.
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 human immunodeficiency virus (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 Programmed Cell Death Ligand 1 (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
Locations
Locations (5)
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
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